Indinavir

Crixivan

Grapefruit and grapefruit juice may interact with indinavir and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you are breastfeeding. Do not breastfeed. It is not known if indinavir can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with indinavir, and some drugs should not be used together.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, diarrhea, lower back pain, and blood in your urine.

Take indinavir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking indinavir without checking first with your doctor.

Indinavir is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment. Your dose of indinavir may depend on the other medicines you are using.

indinavir comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

indinavir should be taken with water on an empty stomach (1 hour before or 2 hours after a meal) or with a light meal. Indinavir may also be taken with other liquids (eg, skim milk, juice, coffee, or tea) or with a light meal (eg, dry toast with jelly, juice, coffee with skim milk and sugar, or corn flakes with skim milk and sugar).

While you are taking indinavir, it is important that you drink extra fluids so that you will pass more urine. This will help prevent possible kidney stones. Follow your doctor's instructions carefully about how much fluid to drink. Usually you will need to drink at least 48 ounces (1.5 liters or 6 full glasses) of fluids every day during your treatment.

Keep taking indinavir for the full time of treatment, even if you begin to feel better.

indinavir works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take three doses a day, the doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed specially for you. Do not share your medicine with others.

If you miss a dose or forget to use your medicine less than 2 hours, use it as soon as you can. If your next regular dose is more than 2 hours, wait until then to use the medicine and skip the missed dose.

Dosing

The dose of indinavir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of indinavir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For treatment of HIV infection:
    • Adults—800 milligrams (mg) every 8 hours. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Indinavir capsules are very sensitive to moisture. Keep them in their original container and leave the drying packet in the container.

• Store at room temperature.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about indinavir, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about indinavir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using indinavir.

Review Date: October 4, 2017

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Concerns related to adverse effects:

• Fat redistribution: May cause redistribution of fat (eg, buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance).

• Hemolytic anemia: Has been associated with acute hemolytic anemia, sometimes fatal; discontinue if hemolytic anemia occurs.

• Hyperbilirubinemia: Indirect hyperbilirubinemia has been observed frequently and has infrequently been associated with serum transaminase elevations. Do not use concurrently with atazanavir.

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves' disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.

• Nephrolithiasis/urolithiasis: May cause nephrolithiasis/urolithiasis, sometimes associated with renal impairment, acute renal failure, or pyelonephritis (with or without bacteremia). Adequate hydration is recommended. Risk is substantially higher in pediatric patients versus adults. Signs/symptoms may require temporary interruption of therapy (1 to 3 days) or discontinuation.

• Tubulointerstitial nephritis: Tubulointerstitial nephritis with medullary calcification and cortical atrophy has been observed in patients with asymptomatic severe leukocyturia (>100 cells/high power field). Closely monitor patients with asymptomatic severe leukocyturia and perform frequent urinalysis; further diagnostic evaluation may be warranted. Discontinuation should be considered in all patients with severe leukocyturia.

Disease-related concerns:

• Diabetes: Changes in glucose tolerance, hyperglycemia, exacerbation of diabetes, DKA, and new-onset diabetes mellitus have been reported in patients receiving protease inhibitors.

• Hemophilia A or B: Use with caution in patients with hemophilia A or B; increased bleeding during protease inhibitor therapy has been reported.

• Hepatic impairment: May cause hepatitis, sometimes resulting in fatal hepatic failure; use with caution in patients with underlying hepatic disease, and decrease dosage in patients with hepatic impairment due to cirrhosis.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Adverse events were observed in some animal reproduction studies. Placental passage in humans with unboosted dosing is minimal. No increased risk of overall birth defects has been observed according to data collected by the antiretroviral pregnancy registry. A small increased risk of preterm birth has been associated with maternal use of protease inhibitor-based combination antiretroviral therapy during pregnancy; however, the benefits of use generally outweigh this risk and protease inhibitors (PIs) should not be withheld if otherwise recommended. Information related to stillbirth, low birth weight, and small for gestational age infants is limited. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children who develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential mitochondrial dysfunction. Hyperbilirubinemia may occur in neonates following in utero exposure to indinavir. Hyperglycemia, new onset of diabetes mellitus, or diabetic ketoacidosis have been reported with PIs; it is not clear if pregnancy increases this risk.

Combination antiretroviral therapy (cART) therapy is recommended for all HIV-infected pregnant women to keep the viral load below the limit of detection and reduce the risk of perinatal transmission. When HIV is diagnosed during pregnancy in a woman who has never received antiretroviral therapy, cART should begin as soon as possible after diagnosis. The Health and Humans Services (HHS) Perinatal HIV Guidelines do not recommend indinavir for initial therapy in antiretroviral-naive pregnant women due to concerns regarding maternal kidney stones or maternal hyperbilirubinemia; if used, must be given in combination with low-dose ritonavir boosting during pregnancy although the optimal dose has not yet been established. Plasma concentrations of unboosted indinavir are decreased during pregnancy. In general, women who become pregnant on a stable cART regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated. Monitoring during pregnancy is more frequent than in non-pregnant adults; cART should be continued postpartum.

For HIV-infected couples planning a pregnancy, maximum viral suppression with cART is recommended prior to conception for the HIV-infected partner(s) and expert consultation is recommended; modification of therapy (if needed) and optimization of the woman’s health should be done prior to conception. HIV-infected women not planning a pregnancy may use any available type of contraception, considering possible drug interactions and contraindications of the specific method. In addition, consistent use of condoms is also recommended (even during pregnancy) to prevent transmission of HIV or other sexually transmitted diseases.

Health care providers are encouraged to enroll pregnant women exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263 or www.APRegistry.com). Health care providers caring for HIV-infected women and their infants may contact the National Perinatal HIV Hotline (888-448-8765) for clinical consultation (HHS [perinatal] 2016).

(Not approved by FDA)

CDC recommendations:
Alternate expanded regimen for HIV postexposure prophylaxis:
Preferred dosing: Indinavir 800 mg plus ritonavir 100 mg orally twice a day, in combination with (lamivudine plus zidovudine) or (emtricitabine plus zidovudine) or (lamivudine plus tenofovir) or (emtricitabine plus tenofovir)

Alternative dosing: Indinavir 800 mg orally every 8 hours, on an empty stomach, in combination with (lamivudine plus zidovudine) or (emtricitabine plus zidovudine) or (lamivudine plus tenofovir) or (emtricitabine plus tenofovir)

Duration: Generally 28 days; however, the exact duration of therapy may differ based on the institution's protocol.

Prophylaxis should be initiated immediately, preferably within hours after exposure.

Indinavir is best taken with water on an empty stomach 1 hour before or 2 hours after a meal. Alternatively, it may be taken with other liquids or a light meal (dry toast with jelly, juice, coffee with skim milk and sugar, or corn flakes with skim milk and sugar). It should not be taken with a high calorie, fat, or protein meal because absorption is reduced. Indinavir/ritonavir may be taken without regard to meals.

The DHHS Panel on Clinical Practices for Treatment of HIV Infection does not recommend unboosted indinavir as initial therapy due to the frequency of administration and need to take on an empty stomach or with light meals.

If possible, protease inhibitors should be used in combination with 2 nucleoside analogs since triple therapy appears to be the most potent antiretroviral combination available. However, one nucleoside plus a protease inhibitor may be effective if drug intolerance prevents the use of triple therapy.

Indinavir capsules are sensitive to moisture. Patients should be instructed to store and use the drug from the original container and keep the desiccant in the bottle.