Norvir

Black Box Warnings

Coadministration with sedative-hypnotics, antiarrhythmics, or ergot alkaloids may result in serious and/or life-threatening adverse events due to ritonavir’s effect on hepatic metabolism

Ritonavir inhibits CYP450 3A; drugs that are extensively metabolized by CYP3A and have high first pass metabolism are most susceptible to increased serum levels when coadministered

Contraindications

Known hypersensitivity to ritonavir (eg, toxic epidermal necrolysis, Stevens- Johnson syndrome)

Coadministration with drugs highly dependent on CYP3A for clearance or that significantly reduce ritonavir

Coadministration of ritonavir with the following drugs is contraindicated: alfuzosin, amiodarone, flecainide, propafenone, quinidine, voriconazole, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, lurasidone, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, carbamazepine, ranolazine, dronedarone, flecainide, colchicine, phenobarbital, phenytoin, and St. John’s wort

Cautions

Do not administer with antacids; separate from didanosine by 2 hr

Potent inhibitor of CYP3A4 (but also induces CYP450 enzymes)

Monitor: monthly neurologic evaluation

Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs

Risks of hemolytic anemia and hyperbilirubinemia if used in combination with other antiretroviral drugs

Capsules must be kept refrigerated

Allergic reactions have been reported and include anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson Syndrome, bronchospasm and angioedema; discontinue treatment if severe reactions develop

Consider drug-drug interaction potential to reduce risk of serious or life-threatening adverse reactions

Oral solution not for administration in preterm neonates in the immediate postnatal period; may cause toxicity; safety and efficacy not established

Monitor liver function before and during therapy, especially in patients with underlying hepatic disease, including hepatitis B and hepatitis C, or marked transaminase elevations; fatalities resulting from hepatic reactions reported

Fatalities resulting from pancreatitis reported; suspend therapy as clinically appropriate

PR interval prolongation reported in some patients; cases of second and third degree heart block reported; use with caution with patients with preexisting conduction system disease, ischemic heart disease, cardiomyopathy, underlying structural heart disease or when administering with other drugs that may prolong the PR interval

Total cholesterol and triglycerides elevations may occur; monitor prior to therapy and periodically thereafter

Patients may develop new onset or exacerbations of diabetes mellitus, hyperglycemia

Patients may develop redistribution/accumulation of body fat

Spontaneous bleeding may occur; additional factor VIII may be required

The recommended dose for adults is 600 mg twice daily. To reduce the occurrence of side effects, ritonavir should be started at 300 mg twice daily and increased every 2-3 days by 100 mg twice daily.

The recommended dose for children older than 1 month is 350 to 400 mg/m2 two times a day and should not exceed 600 mg two times daily. Treatment should be started at 250 mg/m2 and increased every 2-3 days by 50 mg/m2 two times daily.

Ritonavir should be administered with meals. The taste of the oral solution can be improved by mixing it with chocolate milk, Ensure or Advera for up to one hour before administration.

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Reviewed on 7/23/2015 References Reference: FDA Prescribing Information

Ritonavir may interact with many different types of medicines, in some cases causing severe (sometimes fatal) reactions. Consult your doctor or pharmacist about which medications should not be taken with ritonavir. (See also Drug Interactions section.)

Ritonavir interacts with many medications. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: alfuzosin, certain antiarrhythmics (amiodarone, flecainide, propafenone, quinidine), certain benzodiazepines (midazolam, triazolam), bosentan, conivaptan, disulfiram, eletriptan, ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), lurasidone, pimozide, quinine, ranolazine, certain "statin" cholesterol drugs (simvastatin, lovastatin), St John's wort, voriconazole.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting ritonavir.Other medications can affect the removal of ritonavir from your body, which may affect how ritonavir works. Examples include boceprevir, rifampin, other HIV drugs (such as delavirdine), among others.Ritonavir can slow down or speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cisapride, digoxin, fluticasone, salmeterol, theophylline, certain antiarrhythmics (including disopyramide, mexiletine), antidepressants (such as fluoxetine, nefazodone, trazodone), certain beta blockers (metoprolol, timolol), certain "blood thinners" (such as rivaroxaban, warfarin), calcium channel blockers (such as nifedipine, felodipine), some cancer drugs (such as dasatinib, sunitinib, vincristine), certain azole fungal medications (ketoconazole, itraconazole), anti-seizure drugs (including carbamazepine, phenytoin), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil), certain "statin" cholesterol drugs (atorvastatin, rosuvastatin), narcotic pain medications (such as fentanyl, methadone, meperidine), among others.If any of these medications are taken with ritonavir, your doctor may change your dose of ritonavir or the other drug(s), or your doctor may monitor you specially. Consult your doctor or pharmacist for more details.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Ritonavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Ritonavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Ritonavir is not a cure for HIV or AIDS.

Ritonavir may also be used for purposes not listed in this medication guide.

Many other drugs can interact with ritonavir. There are certain medicines that can cause life-threatening drug interactions with ritonavir, and should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

You should not take ritonavir if you are allergic to it.

There are certain medicines that can cause life-threatening drug interactions with ritonavir, and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alfuzosin;
• cisapride;
• pimozide;
• St. John's wort;
• sildenafil (Revatio) when used to treat pulmonary arterial hypertension (PAH);
• voriconazole;
• cholesterol-lowering medicine--lovastatin, simvastatin;
• ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine;
• heart rhythm medicine--amiodarone, flecainide, propafenone, quinidine; or
• a sedative--oral midazolam or triazolam.

To make sure ritonavir is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B or C);
• pancreas disorder;
• diabetes;
• heart disease or heart rhythm disorder;
• a bleeding disorder such as hemophilia; or
• high cholesterol or triglycerides.

This medication is not expected to be harmful to an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Ritonavir can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking ritonavir.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, skin sores, mouth sores; joint or muscle pain; wheezing, difficulty breathing, fast or pounding heartbeats; sweating, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop taking ritonavir and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• irregular heartbeats;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Ritonavir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with ritonavir. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
• cold sores, sores on your genital or anal area;
• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

• nausea, vomiting, stomach pain, diarrhea;
• numbness or tingling, especially around your mouth;
• weakness, tired feeling;
• mild rash; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if:

• you are pregnant or planning to become pregnant: The effects of Norvir on pregnant women or their unborn babies are not known.
• you are breastfeeding: Do not breastfeed if you are taking Norvir. You should not breastfeed if you have HIV. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby. You should be aware that if your baby does not already have HIV, there is a chance that HIV can be transmitted through breastfeeding.
• you have liver problems: If you have liver problems or are infected with Hepatitis B or Hepatitis C, you should tell your doctor before taking Norvir.
• you have diabetes: Some people taking protease inhibitors develop new or more serious diabetes or high blood sugar. Be sure to tell your doctor if you have diabetes or an increase in thirst and/or frequent urination.
• you have hemophilia: Some people with hemophilia have had increased bleeding. It is not known whether the protease inhibitors caused these problems. Be sure to tell your doctor if you have hemophilia types A and B.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of ritonavir oral liquid could be fatal to a child.

Ritonavir capsules and oral liquid contain alcohol. Avoid drinking alcoholic beverages while using this medicine, and do not take disulfiram (Antabuse) or you could have an alcohol reaction.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Norvir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

General Dosing and Administration Recommendations

• Norvir must be used in combination with other antiretroviral agents.
• Norvir is administered orally in combination with other antiretroviral agents. It is recommended that Norvir be taken with meals.

General Dosing Guidelines

Patients should be aware that frequently observed adverse events, such as mild to moderate gastrointestinal disturbances and paraesthesias, may diminish as therapy is continued.

Recommended Adult Dosage

Recommended Dosage for treatment of HIV-1

The recommended dosage of Norvir is 600 mg twice daily by mouth. Use of a dose titration schedule may help to reduce treatment-emergent adverse events while maintaining appropriate ritonavir plasma levels. Norvir should be started at no less than 300 mg twice daily and increased at 2 to 3 day intervals by 100 mg twice daily. The maximum dose of 600 mg twice daily should not be exceeded upon completion of the titration.

Recommended Pediatric Dosage

Norvir must be used in combination with other antiretroviral agents [see Dosage and Administration (2)]. The recommended dosage of Norvir in pediatric patients older than 1 month is 350 to 400 mg per m2 twice daily by mouth and should not exceed 600 mg twice daily. Norvir should be started at 250 mg per m2 twice daily and increased at 2 to 3 day intervals by 50 mg per m2 twice daily. If patients do not tolerate 400 mg per m2 twice daily due to adverse events, the highest tolerated dose may be used for maintenance therapy in combination with other antiretroviral agents, however, alternative therapy should be considered. The use of Norvir oral solution is recommended for children greater than 1 month who cannot swallow capsules. Please refer to the Norvir oral solution full prescribing information for pediatric dosage and administration.

When co-administering Norvir with other protease inhibitors, see the full prescribing information for the co-administered protease inhibitor including important information for use in special populations.

Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Norvir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1–800–258–4263.

Risk Summary

Prospective pregnancy data from the Antiretroviral Pregnancy Registry (APR) are not sufficient to adequately assess the risk of birth defects or miscarriage. Available data from the APR show no difference in the rate of overall birth defects for ritonavir compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) [see Data ].

In animal reproduction studies, no evidence of adverse developmental outcomes was observed with oral administration of ritonavir to pregnant rats and rabbits. During organogenesis in the rat and rabbit, systemic exposure (AUC) was approximately 1/3 lower than human exposure at the recommended daily dose. In the rat pre- and post-natal developmental study, maternal systemic exposure to ritonavir was approximately 1/2 of the exposure in humans at the recommended daily dose, based on a body surface area conversion factor [see Data].

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Human Data

Based on prospective reports to the APR of approximately 6100 live births following exposure to ritonavir-containing regimens (including over 2800 live births exposed in the first trimester and over 3200 live births exposed in the second and third trimesters), there was no difference in the rate of overall birth defects for ritonavir compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP. The prevalence of birth defects in live births was 2.3% (95% CI: 1.7%-2.9%) following first-trimester exposure to ritonavir-containing regimens and 2.9% (95% CI: 2.3%-3.5%) following second and third trimester exposure to ritonavir-containing regimens.

While placental transfer of ritonavir and fetal ritonavir concentrations are generally low, detectable levels have been observed in cord blood samples and neonate hair.

Animal Data

Ritonavir was administered orally to pregnant rats (at 0, 15, 35, and 75 mg/kg/day), and rabbits (at 0, 25, 50, and 110 mg/kg/day) during organogenesis (on gestation days 6 through 17 and 6 through 19, respectively). No evidence of teratogenicity due to ritonavir was observed in rats and rabbits at doses producing systemic exposures (AUC) equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. Developmental toxicity observed in rats (early resorptions, decreased fetal body weight and ossification delays and developmental variations) occurred at a maternally toxic dose at an exposure equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. A slight increase in the incidence of cryptorchidism was also noted in rats (at a maternally toxic dose) at an exposure approximately 1/5 lower than human exposure at the recommended daily dose. Developmental toxicity was observed in rabbits (resorptions, decreased litter size and decreased fetal weights) at maternally toxic dosage equivalent to 1.8 times higher than the recommended daily dose, based on a body surface area conversion factor. In pre-and postnatal development study in rats, ritonavir was administered at doses of 0, 15, 35, and 60 mg/kg/day from gestation day 6 through postnatal day 20. At doses of 60 mg/kg/day, no developmental toxicity was noted with ritonavir dosage equivalent to 1/2 of the recommended daily dose, based on a body surface area conversion factor.

Lactation

Risk Summary

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.

Limited published data reports that ritonavir is present in human milk.

There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. Because of the potential for (1) HIV transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants) and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving Norvir.

Females and Males of Reproductive Potential

Contraception

Use of Norvir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception [see Drug Interactions (7.3)].

Pediatric Use

In HIV-1 infected patients age greater than 1 month to 21 years, the antiviral activity and adverse event profile seen during clinical trials and through postmarketing experience were similar to that for adult patients.

Geriatric Use

Clinical studies of Norvir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Impairment

No dose adjustment of ritonavir is necessary for patients with either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of ritonavir in subjects with severe hepatic impairment (Child-Pugh Class C), therefore, ritonavir is not recommended for use in patients with severe hepatic impairment [see Warnings and Precautions (5.2), and Clinical Pharmacology (12.3)].

Advise the patient to read the FDA-approved patient labeling (Patient information).

General Information

• Advise patients and caregivers to pay special attention to accurate administration of their dose to minimize the risk of accidental overdose or underdose of Norvir.
• Advise caregivers to inform their healthcare provider if their children’s weight changes in order to make sure that the child’s Norvir dose is adjusted as needed.
• Advise patients to take Norvir with meals.
• For adult patients taking Norvir capsules, the maximum dose of 600 mg twice daily by mouth with meals should not be exceeded.
• Advise patients to remain under the care of a physician while using Norvir and to take Norvir and other concomitant antiretroviral therapy every day as prescribed. Norvir must always be used in combination with other antiretroviral drugs. Advise patients not to alter the dose or discontinue therapy without consulting with their healthcare provider. If a dose of Norvir is missed patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped the patient should not double the next dose.
• Continued Norvir therapy at a dose of 600 mg twice daily following loss of viral suppression may increase the likelihood of cross-resistance to other protease inhibitors.
• Norvir is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using Norvir.

Drug Interactions

• Norvir may interact with some drugs; therefore, patients should be advised to report to their doctor the use of any other prescription, non-prescription medication or herbal products, particularly St. John's Wort.
• Instruct patients receiving combined hormonal contraception to use an effective alternative contraceptive method or an additional barrier method during therapy with Norvir because hormonal levels may decrease [see Drug Interactions (7.3), Use in Specific Populations (8.3)].

Hepatotoxicity

Pre-existing liver disease including Hepatitis B or C can worsen with use of Norvir. This can be seen as worsening of transaminase elevations or hepatic decompensation. Advise patients that their liver function tests will need to be monitored closely especially during the first several months of Norvir treatment and that they should notify their healthcare provider if they develop the signs and symptoms of worsening liver disease including loss of appetite, abdominal pain, jaundice, and itchy skin [see Warnings and Precautions (5.3)].

Pancreatitis

Pancreatitis, including some fatalities, has been observed in patients receiving Norvir therapy. Advise patients to notify their healthcare provider of signs and symptoms (nausea, vomiting, and abdominal pain) that might be suggestive of pancreatitis [see Warnings and Precautions (5.4)].

Allergic Reactions/Hypersensitivity

Skin rashes ranging in severity from mild to Stevens-Johnson syndrome have been reported in patients receiving Norvir. Advise patients to contact their healthcare provider if they develop a rash while taking Norvir [see Warnings and Precautions (5.5)].

PR Interval Prolongation

Norvir may produce changes in the electrocardiogram (e.g., PR prolongation). Advise patients to consult their healthcare provider if they experience symptoms such as dizziness, lightheadedness, abnormal heart rhythm or loss of consciousness [see Warnings and Precautions (5.6)].

Lipid Disorders

Advise patients that treatment with Norvir therapy can result in substantial increases in the concentration of total cholesterol and triglycerides [see Warnings and Precautions (5.7)].

Diabetes Mellitus/Hyperglycemia

Advise patients that new onset of diabetes or exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported and to notify their healthcare provider if they develop the signs and symptoms of diabetes mellitus including frequent urination, excessive thirst, extreme hunger or unusual weight loss and/or an increased blood sugar while on Norvir as they may require a change in their diabetes treatment or new treatment [see Warnings and Precautions (5.7)].

Immune Reconstitution Syndrome

Advise patients that immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including Norvir [see Warnings and Precautions (5.9)].

Fat Redistribution

Advise patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long term health effects of these conditions are not known at this time [see Warnings and Precautions (5.10)].

Patients with Hemophilia

Advise patients with hemophilia that they may experience increased bleeding when treated with protease inhibitors such as Norvir [see Warnings and Precautions (5.11)].

Pregnancy Exposure Registry

Inform patients that there is an antiretroviral pregnancy registry that monitors fetal outcomes of pregnant women exposed to Norvir [see Use in Specific Populations (8.1)].

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2)].

Norvir 100 mg soft gelatin capsules are manufactured for:

AbbVie Inc.
North Chicago, IL 60064 USA

©2017 AbbVie Inc. All rights reserved.

		Patient Information Norvir® (NOR-VEER) (ritonavir) Soft Gelatin Capsules
What is the most important information I should know about Norvir? Norvir can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with Norvir. See the section “Who should not take Norvir?”
What is Norvir? Norvir capsules are prescription medicines that are used with other antiviral medicines to treat people with human immunodeficiency virus (HIV-1) infection. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
Do not take Norvir if you or your child: are allergic to ritonavir or any of the ingredients in Norvir. See the end of this leaflet for a complete list of ingredients in Norvir. take any of the following medicines: alfuzosin (UROXATRAL®) amiodarone (CORDARONE®, NEXTERONE®, PACERONE®) cisapride (PROPULSID®, PROPULSID QUICKSOLV®) colchicine (COLCRYS®, COL-PROBENECID®, Probenecid and Colchine) dronedarone (MULTAQ®) ergot-containing medicines, including: dihydroergotamine (D.H.E. 45®, MIGRANAL®) ergotamine tartrate (CAFERGOT®, MIGEROT®, ERGOSTAT®, MEDIHALER ERGOTAMINE®, WIGRAINE®, WIGRETTES® ) methylergonovine maleate (ERGOTRATE®, METHERGINE®) flecainide (TAMBOCOR®) lovastatin (ADVICOR®, ALTOPREV®, MEVACOR®) lurasidone (LATUDA®) midazolam, when taken by mouth pimozide (ORAP®) propafenone (RYTHMOL®) quinidine (NUEDEXTA®, QUINAGLUTE®, CARDIOQUIN®, QUINIDEX®, and others) ranolazine (RANEXA®) sildenafil (REVATIO®) only when used for treating the lung problem, pulmonary arterial hypertension (PAH) simvastatin (SIMCOR®, VYTORIN®, ZOCOR®) St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s wort triazolam (HALCION®) voriconazole (VFEND®) if your Norvir dose is 400 mg every 12 hours or greater Serious problems can happen if you or your child takes any of these medicines with Norvir.
Before taking Norvir, tell your healthcare provider about all of your medical conditions, including if you or your child: have liver problems, including Hepatitis B or Hepatitis C have heart problems have high blood sugar (diabetes) have bleeding problems or hemophilia are pregnant or plan to become pregnant. Norvir may reduce how well hormonal birth control works. Females who may become pregnant should use another effective form of birth control or an additional barrier method of birth control during treatment with Norvir. Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. Do not breastfeed if you take Norvir. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Norvir may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with Norvir. Keep a list of your medicines to show our healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Norvir. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Norvir with other medicines.
How should I take Norvir? Take Norvir exactly as your healthcare provider tells you to take it. You should stay under a healthcare provider's care during treatment with Norvir. Do not change your dose of Norvir or stop your treatment without talking with your healthcare provider first. If your child is taking Norvir, your child’s healthcare provider will decide the right dose based on your child's height and weight. Tell your healthcare provider if your child’s weight changes. Swallow Norvir capsules whole. Do not chew, break, or crush capsules before swallowing. If you cannot swallow Norvir capsules whole, tell your healthcare provider. You may need a different medicine. Take Norvir with meals. Do not run out of Norvir. Get your Norvir prescription refilled from your healthcare provider or pharmacy before you run out. If you miss a dose of Norvir, take it as soon as possible and then take your next scheduled dose at its regular time. If it is almost time for your next dose, wait and take the next dose at the regular time. Do not double the next dose. If you take too much Norvir, call your local poison control center or go to the nearest hospital emergency room right away.
What are the possible side effects of Norvir? Norvir can cause serious side effects including: See “What is the most important information I should know about Norvir?” Liver problems. Some people taking Norvir in combination with other antiviral medicines have developed liver problems which may be life-threatening. Your healthcare provider should do regular blood tests during your combination treatment with Norvir. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems:
loss of appetite pain or tenderness on your right side below your ribs			yellowing of your skin or whites of your eyes itchy skin
Inflammation of your pancreas (pancreatitis). Norvir can cause serious pancreas problems, which may lead to death. Tell your healthcare provider right away if you have signs or symptoms of pancreatitis such as:
nausea stomach (abdomen) pain			vomiting
Allergic reactions. Sometimes these allergic reactions can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking Norvir and get medical help right away if you have any of the following symptoms of a severe allergic reaction:
trouble breathing wheezing dizziness or fainting throat tightness or hoarseness fast heartbeat or pounding in your chest (tachycardia)			sweating swelling of your face, lips or tongue muscle or joint pain blisters or skin lesions mouth sores or ulcers
Changes in the electrical activity of your heart called PR prolongation. PR prolongation can cause irregular heartbeats. Tell your healthcare provider right away if you have symptoms such as:
dizziness lightheadedness			feel faint or pass out abnormal heart beat
Increase in cholesterol and triglyceride levels. Treatment with Norvir may increase your blood levels of cholesterol and triglycerides. Your healthcare provider should do blood tests before you start your treatment with Norvir and regularly to check for an increase in your cholesterol and triglycerides levels. Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including Norvir can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often during treatment with Norvir. Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine. Change in body fat can happen in some people who taking HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known. Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including Norvir. The most common side effects of Norvir include:
diarrhea nausea vomiting upper and lower stomach (abdominal) pain			tingling feeling or numbness in hands or feet or around the lips rash feeling weak or tired
These are not all of the possible side effects of Norvir. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Norvir? Protect Norvir from light. Keep Norvir away from heat. Store Norvir tightly closed in the original container. Use Norvir by the expiration date on the bottle. Store Norvir: In the refrigerator between 36°F to 46°F (2°C to 8°C) Norvir soft gelatin capsules may be stored below 77°F (25°C) if used within 30 days. Keep Norvir and all medicines out of the reach of children.
General information about the safe and effective use of Norvir Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Norvir for a condition for which it was not prescribed. Do not give Norvir to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Norvir that is written for healthcare professionals.
What are the ingredients in Norvir? Active ingredient: ritonavir Inactive ingredients: butylated hydroxytoluene, ethanol, gelatin, iron oxide, oleic acid, polyoxyl 35 castor oil, and titanium dioxide Norvir capsule is manufactured for: AbbVie Inc., North Chicago, IL 60064 USA For more information, call 1-800-633-9110. The brands listed are trademarks of their respective owners and are not trademarks of AbbVie Inc. The makers of these brands are not affiliated with and do not endorse AbbVie Inc. or its products. © 2017 AbbVie Inc. All rights reserved.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: June 2017

NDC 0074–6633–30

Norvir®

Ritonavir Capsules Soft Gelatin 100 mg 30 Capsules

ALERT: Find out about medicines that should NOT be taken with Norvir

Note to Pharmacist: Do not cover ALERT box with pharmacy label.

Package insert is provided with tear-off patient information.

Rx only abbvie

Norvir  ritonavir capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0074-6633 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RITONAVIR (RITONAVIR) RITONAVIR 100 mg

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE   ALCOHOL   GELATIN   OLEIC ACID   POLYOXYL 35 CASTOR OIL   TITANIUM DIOXIDE   FERRIC OXIDE RED

Product Characteristics Color WHITE Score no score Shape OVAL Size 22mm Flavor Imprint Code 100;DS Contains

Packaging # Item Code Package Description 1 NDC:0074-6633-22 120 CAPSULE in 1 BOTTLE 2 NDC:0074-6633-30 30 CAPSULE in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020945 05/06/2010

Labeler - AbbVie Inc. (078458370)

Revised: 06/2017   AbbVie Inc.

Serious drug interactions can occur when certain medicines are used with Norvir. Tell your doctor about all your current medicines and any you start or stop using.

Taking Norvir will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.