Rescriptor

Delavirdine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• excessive tiredness
• headache
• nausea
• diarrhea
• rash

Some side effects can be serious. If you experience any of the following symptoms, stop taking delavirdine and call your doctor immediately or get emergency medical treatment:

• rash along with other symptoms such as fever, blistering, sores in the mouth, red or swollen eyes, or muscle or joint pain
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Delavirdine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

If you take too much Rescriptor call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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.

• Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.1 Importance of taking as prescribed; do not alter or discontinue antiretroviral regimen without consulting clinician.1

• Importance of using in conjunction with other antiretroviralsnot for monotherapy.1

• Antiretroviral therapy is not a cure for HIV infection; opportunistic infections and other complications associated with HIV disease may still occur.1

• Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.200 Importance of continuing to practice safer sex (e.g., using latex or polyurethane condoms to minimize sexual contact with body fluids), never sharing personal items that can have blood or body fluids on them (e.g., toothbrushes, razor blades), and never reusing or sharing needles.1 200

• Importance of reading patient information provided by the manufacturer.1

• Importance of patients with achlorhydria taking delavirdine with an acidic beverage.1

• If a dose is missed, the next dose should be taken as soon as possible.1 If a dose is skipped, do not take a double dose to make up for the missed dose.1

• Importance of discontinuing delavirdine and consulting a clinician if severe rash or rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches occurs.1

• Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products (e.g., St. John’s wort), and any concomitant illnesses.1

• Advise patients receiving PDE5 inhibitors (e.g., sildenafil) that they may be at increased risk of PDE5 inhibitor-associated adverse effects (e.g., hypotension, visual disturbances, priapism) and that any symptoms should be promptly reported to their clinician.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Advise HIV-infected women not to breast-feed.1

• Importance of advising patients of other important precautionary information.1 (See Cautions.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Delavirdine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alprazolam
• Astemizole
• Carbamazepine
• Cisapride
• Conivaptan
• Dihydroergotamine
• Eliglustat
• Ergonovine
• Ergotamine
• Fosamprenavir
• Fosphenytoin
• Isavuconazonium Sulfate
• Methylergonovine
• Midazolam
• Naloxegol
• Nimodipine
• Phenytoin
• Pimozide
• Primidone
• Terfenadine
• Tolvaptan
• Triazolam

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Artemether
• Bedaquiline
• Bepridil
• Bosutinib
• Brentuximab Vedotin
• Bupropion
• Cabazitaxel
• Ceritinib
• Cilostazol
• Cimetidine
• Cobicistat
• Crizotinib
• Darunavir
• Delamanid
• Domperidone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Etravirine
• Famotidine
• Flecainide
• Idelalisib
• Ifosfamide
• Ixabepilone
• Ketoconazole
• Lansoprazole
• Lidocaine
• Lovastatin
• Lumefantrine
• Lurasidone
• Methadone
• Nevirapine
• Nizatidine
• Olaparib
• Omeprazole
• Panobinostat
• Paroxetine
• Phenobarbital
• Piperaquine
• Propafenone
• Quinidine
• Ranitidine
• Rifabutin
• Rifampin
• Rilpivirine
• Ruxolitinib
• Saquinavir
• Simeprevir
• Simvastatin
• St John's Wort
• Tacrolimus
• Vilazodone
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amprenavir
• Cerivastatin
• Clarithromycin
• Dalfopristin
• Desogestrel
• Didanosine
• Dienogest
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Drospirenone
• Ergoloid Mesylates
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fluoxetine
• Indinavir
• Lacidipine
• Lercanidipine
• Levonorgestrel
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Manidipine
• Medroxyprogesterone Acetate
• Mestranol
• Nelfinavir
• Nilvadipine
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Quinupristin
• Rifapentine
• Ritonavir
• Sildenafil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Achlorhydria (absence of stomach acid)—Delavirdine should be taken with an acidic beverage such as orange or cranberry juice

• Liver disease—Effects of delavirdine may be increased because of slower removal from the body

It is very important that your doctor check your progress at regular visits.

Rescriptor Tablets contain delavirdine mesylate, a synthetic non-nucleoside reverse transcriptase inhibitor (NNRTI) of the human immunodeficiency virus type 1 (HIV-1). The chemical name of delavirdine mesylate is piperazine, 1-[3-[(1-methyl-ethyl)amino]-2- pyridinyl]-4-[[5-[(methylsulfonyl)amino]-1H-indol-2-yl]carbonyl]-, monomethanesulfonate. Its molecular formula is C22H28N6O3S•CH4O3S, and its molecular weight is 552.68. The structural formula is:

Delavirdine mesylate is an odorless white-to-tan crystalline powder. The aqueous solubility of delavirdine free base at 23°C is 2,942 mcg/mL at pH 1.0, 295 mcg/mL at pH 2.0, and 0.81 mcg/mL at pH 7.4.

Each Rescriptor Tablet, for oral administration, contains 100 or 200 mg of delavirdine mesylate (henceforth referred to as delavirdine). Inactive ingredients consist of carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, and microcrystalline cellulose. In addition, the 100-mg tablet contains Opadry White YS-1-7000-E and the 200-mg tablet contains hypromellose and Opadry White YS-1-18202-A.

The safety of Rescriptor Tablets alone and in combination with other therapies has been studied in approximately 6,000 patients receiving Rescriptor. The majority of adverse events were of mild or moderate (i.e., ACTG Grade 1 or 2) intensity. The most frequently reported drug-related adverse event (i.e., events considered by the investigator to be related to the blinded study medication or events with an unknown or missing causal relationship to the blinded medication) among patients receiving Rescriptor was skin rash (see Table 8 and PRECAUTIONS: Skin Rash).

Table 8. Percent of Patients With Treatment-Emergent Rash in Pivotal Trials (Studies 21 Part II and 13C)a

Percent of Patients With:	Description of Rash Gradeb	Rescriptor 400 mg t.i.d. (n = 412)	Control Group Patients (n = 295)
Grade 1 rash	Erythema, pruritus	69 (16.7%)	35 (11.9%)
Grade 2 rash	Diffuse maculopapular rash, dry desquamation	59 (14.3%)	17 (5.8%)
Grade 3 rash	Vesiculation, moist desquamation, ulceration	18 (4.4%)	0 (0.0%)
Grade 4 rash	Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative dermatitis	0 (0.0%)	0 (0.0%)
Rash of any grade		146 (35.4%)	52 (17.6%)
Treatment discontinuation as a result of rash		13 (3.2%)	1 (0.3%)

aIncludes events reported regardless of causality.

bACTG Toxicity Grading System; includes events reported as “rash,” “maculopapular rash,” and “urticaria.”

Adverse events of moderate to severe intensity reported by at least 5% of evaluable patients in any treatment group in the pivotal trials, which includes patients receiving Rescriptor in combination with zidovudine and/or lamivudine in Study 21 Part II for up to 98 weeks and in combination with zidovudine and either lamivudine, didanosine, or zalcitabine in Study 13C for up to 72 weeks are summarized in Table 9.

Table 9. Treatment-Emergent Events Regardless of Causality, of Moderate-to-Severe or Life-Threatening Intensity Reported by at Least 5% of Evaluablea Patients in Any Treatment Group

	Study 21 Part II			Study 13C
	Zidovudine + Lamivudine (n = 123)	400 mg t.i.d. Rescriptor + Zidovudine (n = 123)	400 mg t.i.d. Rescriptor + Zidovudine + Lamivudine (n = 119)	Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 172)	400 mg t.i.d. Rescriptor + Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 170)
Adverse Events	% of pts. (n)	% of pts. (n)	% of pts. (n)	% of pts. (n)	% of pts. (n)
Body as a Whole
Abdominal pain, generalized	2.4 (3)	3.3 (4)	5.0 (6)	1.7 (3)	2.4 (4)
Asthenia/fatigue	16.3 (20)	15.4 (19)	16.0 (19)	8.1 (14)	5.3 (9)
Fever	2.4 (3)	1.6 (2)	3.4 (4)	6.4 (11)	7.1 (12)
Flu syndrome	4.9 (6)	7.3 (9)	5.0 (6)	5.2 (9)	2.4 (4)
Headache	14.6 (18)	12.2 (15)	16.8 (20)	12.8 (22)	11.2 (19)
Localized pain	4.9 (6)	5.7 (7)	5.0 (6)	2.9 (5)	1.8 (3)
Digestive
Diarrhea	8.1 (10)	2.4 (3)	4.2 (5)	8.1 (14)	5.9 (10)
Nausea	17.1 (21)	20.3 (25)	16.8 (20)	9.3 (16)	14.7 (25)
Vomiting	8.9 (11)	4.9 (6)	2.5 (3)	4.1 (7)	6.5 (11)
Nervous
Anxiety	1.6 (2)	2.4 (3)	6.7 (8)	4.1 (7)	3.5 (6)
Depressive symptoms	6.5 (8)	4.9 (6)	12.6 (15)	3.5 (6)	5.9 (10)
Insomnia	4.9 (6)	4.9 (6)	5.0 (6)	2.9 (5)	1.2 (2)
Respiratory
Bronchitis	4.1 (5)	6.5 (8)	6.7 (8)	3.5 (6)	3.5 (6)
Cough	9.8 (12)	4.1 (5)	5.0 (6)	5.2 (9)	3.5 (6)
Pharyngitis	6.5 (8)	1.6 (2)	5.0 (6)	4.1 (7)	3.5 (6)
Sinusitis	8.9 (11)	7.3 (9)	5.0 (6)	2.3 (4)	1.2 (2)
Upper respiratory infection	11.4 (14)	6.5 (8)	7.6 (9)	8.7 (15)	4.7 (8)
Skin
Rashes	3.3 (4)	19.5 (24)	13.4 (16)	7.6 (13)	18.8 (32)

aEvaluable patients in Study 21 Part II were those who received at least 1 dose of study medication and returned for at least 1 clinic study visit. Evaluable patients in Study 13C were those who received at least 1 dose of study medication.

Other Adverse Events in Phase II/III Studies

Other adverse events that occurred in patients receiving Rescriptor (in combination treatment) in all Phase II and III studies, considered possibly related to treatment, and of at least ACTG Grade 2 in intensity are listed below by body system.

Body as a Whole: Abdominal cramps, abdominal distention, abdominal pain (localized), abscess, allergic reaction, chills, edema (generalized or localized), epidermal cyst, fever, infection, infection viral, lip edema, malaise, Mycobacterium tuberculosis infection, neck rigidity, sebaceous cyst, and redistribution/accumulation of body fat (see  PRECAUTIONS: Fat Redistribution).

Cardiovascular System: Abnormal cardiac rate and rhythm, cardiac insufficiency, cardiomyopathy, hypertension, migraine, pallor, peripheral vascular disorder, and postural hypotension.

Digestive System: Anorexia, bloody stool, colitis, constipation, decreased appetite, diarrhea (Clostridium difficile), diverticulitis, dry mouth, dyspepsia, dysphagia, enteritis at all levels, eructation, fecal incontinence, flatulence, gagging, gastroenteritis, gastroesophageal reflux, gastrointestinal bleeding, gastrointestinal disorder, gingivitis, gum hemorrhage, hepatomegaly, increased appetite, increased saliva, increased thirst, jaundice, mouth or tongue inflammation or ulcers, nonspecific hepatitis, oral/enteric moniliasis, pancreatitis, rectal disorder, sialadenitis, tooth abscess, and toothache.

Hemic and Lymphatic System: Adenopathy, bruising, eosinophilia, granulocytosis, leukopenia, pancytopenia, purpura, spleen disorder, thrombocytopenia, and prolonged prothrombin time.

Metabolic and Nutritional Disorders: Alcohol intolerance, amylase increased, bilirubinemia, hyperglycemia, hyperkalemia, hypertriglyceridemia, hyperuricemia, hypocalcemia, hyponatremia, hypophosphatemia, increased AST (SGOT), increased gamma glutamyl transpeptidase, increased lipase, increased serum alkaline phosphatase, increased serum creatinine, and weight increase or decrease.

Musculoskeletal System: Arthralgia or arthritis of single and multiple joints, bone disorder, bone pain, myalgia, tendon disorder, tenosynovitis, tetany, and vertigo.

Nervous System: Abnormal coordination, agitation, amnesia, change in dreams, cognitive impairment, confusion, decreased libido, disorientation, dizziness, emotional lability, euphoria, hallucination, hyperesthesia, hyperreflexia, hypertonia, hypesthesia, impaired concentration, manic symptoms, muscle cramp, nervousness, neuropathy, nystagmus, paralysis, paranoid symptoms, restlessness, sleep cycle disorder, somnolence, tingling, tremor, vertigo, and weakness.

Respiratory System: Chest congestion, dyspnea, epistaxis, hiccups, laryngismus, pneumonia, and rhinitis.

Skin and Appendages: Angioedema, dermal leukocytoclastic vasculitis, dermatitis, desquamation, diaphoresis, discolored skin, dry skin, erythema, erythema multiforme, folliculitis, fungal dermatitis, hair loss, herpes zoster or simplex, nail disorder, petechiae, non-application site pruritus, seborrhea, skin hypertrophy, skin disorder, skin nodule, Stevens-Johnson syndrome, urticaria, vesiculobullous rash, and wart.

Special Senses: Blepharitis, blurred vision, conjunctivitis, diplopia, dry eyes, ear pain, parosmia, otitis media, photophobia, taste perversion, and tinnitus.

Urogenital System: Amenorrhea, breast enlargement, calculi of the kidney, chromaturia, epididymitis, hematuria, hemospermia, impaired urination, impotence, kidney pain, metrorrhagia, nocturia, polyuria, proteinuria, testicular pain, urinary tract infection, and vaginal moniliasis.

Postmarketing Experience

Adverse event terms reported from postmarketing surveillance that were not reported in the Phase II and III trials are presented below.

Digestive System: Hepatic failure.

Hemic and Lymphatic System: Hemolytic anemia.

Musculoskeletal System: Rhabdomyolysis.

Urogenital System: Acute kidney failure.

Laboratory Abnormalities

Marked laboratory abnormalities observed in at least 2% of patients during Studies 21 Part II and 13C are summarized in Table 10. Marked laboratory abnormalities are defined as any Grade 3 or 4 abnormality found in patients at any time during study.

Table 10. Marked Laboratory Abnormalities Reported by ≥2% of Patients

Adverse Events/Toxicity Limits	Study 21 Part II			Study 13C
	Zidovudine + Lamivudine (n = 123)	400 mg t.i.d. Rescriptor + Zidovudine (n = 123)	400 mg t.i.d. Rescriptor + Zidovudine + Lamivudine (n = 119)	Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 172)	400 mg t.i.d. Rescriptor + Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 170)
	% pts.	% pts.	% pts.	% pts.	% pts.
Hematology
Hemoglobin <7 mg/dL	4.1	2.5	0.9	1.7	2.9
Neutrophils <750/mm3	5.7	4.9	3.4	10.4	7.6
Prothrombin time (PT) >1.5 × ULN	0	0	1.7	2.9	2.4
Activated partial thromboplastin (APTT) >2.33 × ULN	0	0.8	0	5.8	2.4
Chemistry
Alananine aminotransferase (ALT/SGPT) >5 × ULN	2.5	4.1	5.1	3.5	4.1
Amylase >2 × ULN	0.8	2.5	2.6	3.5	2.9
Aspartate aminotransferase (AST/SGOT) >5 × ULN	1.6	2.5	3.4	3.5	2.3
Bilirubin >2.5 × ULN	0.8	2.5	1.7	1.2	0
Gamma glutamyl transferase (GGT) >5 × ULN	N/A	N/A	N/A	4.1	1.8
Glucose (hypo-/hyperglycemia) <40 mg/dL >250 mg/dL	4.1	0.8	1.7	1.2	0

N/A = not applicable because no predose values were obtained for patients.

The recommended dosage for Rescriptor Tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. Rescriptor should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.

The 100-mg Rescriptor Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg Rescriptor Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see  CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200-mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200-mg tablets are approximately one-third smaller in size than the 100-mg tablets.

Rescriptor Tablets may be administered with or without food (see  CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). Patients with achlorhydria should take Rescriptor with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.

Patients taking both Rescriptor and antacids should be advised to take them at least 1 hour apart.

Rescriptor Tablets are available as follows:

100-mg: white, capsule-shaped tablets marked with “U 3761”

Bottles of 360 tablets - NDC 49702-209-24.

200-mg: white, capsule-shaped tablets marked with “RES200”

Bottles of 180 tablets - NDC 49702-225-17.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity.

Rescriptor®

(ree-SKRIP-tor)

(delavirdine mesylate) Tablets

Generic name: delavirdine mesylate (de-LAH-vur-deen MESS-ihl-ate)

ALERT: Find out about medicines that should NOT be taken with Rescriptor. Please also read the section "MEDICINES YOU SHOULD NOT TAKE WITH Rescriptor."

Read this information carefully before taking Rescriptor. Also, read this leaflet each time you renew the prescription, just in case anything has changed. This is a summary and not a replacement for a careful discussion with your healthcare provider (doctor, nurse, pharmacist). You and your healthcare provider should discuss Rescriptor when you start taking this medication and at regular checkups. You should remain under a doctor's care when taking Rescriptor and should not change or stop treatment without first talking with your healthcare provider.

What is Rescriptor and how does it work?

Rescriptor is a medicine used in combination with other anti-HIV medicines to treat people with HIV-1 infection. Infection with HIV-1 leads to the destruction of infection-fighting immune system cells (called CD4+ cells or T cells), which are important to the immune system. After a large number of CD4+ cells have been destroyed, the infected person develops acquired immune deficiency syndrome (AIDS).

Rescriptor helps to block HIV-1 reverse transcriptase, a chemical the virus uses to make more copies of itself. The main goals of anti-HIV medicines like Rescriptor are to decrease the amount of virus in your blood (called viral load) and to increase the number of CD4+ cells as much as possible for as long as possible.

Rescriptor, when taken with other anti-HIV medicines, lowers the HIV-1 viral load in patients. Patients who took Rescriptor as part of combination therapy for HIV-1 also had increases in their CD4+ cell count.

General information about Rescriptor

Rescriptor does not cure HIV-1 or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Rescriptor.

Avoid doing things that can spread HIV-1 infection.

• Do not share needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

How should I take Rescriptor?

• You should stay under a healthcare provider's care when taking Rescriptor. Do not change your treatment or stop treatment without first talking with your healthcare provider. • You must take Rescriptor every day exactly as your healthcare provider prescribes it. Follow the directions from your healthcare provider, exactly as written on the label. • The usual dose of Rescriptor is two 200‑mg tablets 3 times a day or four 100‑mg tablets 3 times a day, in combination with other anti-HIV-1 medicines. Either way, your total daily dose of Rescriptor remains the same. • You can take Rescriptor with or without food. • If you have trouble swallowing tablets, the 100‑mg Rescriptor tablets may be dissolved in water. Place 4 tablets in at least 3 ounces of water and allow the tablets to sit in the water for a few minutes. Then, stir the water until the tablets have dissolved and drink the mixture right away. Add a little more water, swirl, and then drink the rest of the mixture to be sure that you get all the medicine. The 200‑mg tablets must be swallowed whole. They cannot be dissolved in water. • Many people find it easier to take their Rescriptor with breakfast, lunch, and dinner, since food does not interfere with Rescriptor. It is a good idea to get into the habit of taking Rescriptor on a regular schedule to make it easier to remember. Figure out things that happen every day at pill-taking time and take your tablets then. By taking your medicine along with activities you do every day, such as getting up in the morning, brushing your teeth, eating lunch, coming home from work in the evening, or watching a favorite TV show, you will find it easier to remember to take every dose. • When your supply of Rescriptor starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Rescriptor and become harder to treat. • Only take medicine that has been prescribed specifically for you. Do not give Rescriptor to others or take medicine prescribed for someone else.

What should I do if I miss a dose of Rescriptor?

If you forget to take a dose of Rescriptor, take it as soon as possible. However, if you skip the dose entirely, do not double the next dose. If you forget a lot of doses, talk to your healthcare provider about how you should continue taking your medicine.

Who should not take Rescriptor?

Together with your healthcare provider, you need to decide whether Rescriptor is right for you.

• Do not take Rescriptor if you are taking certain medicines. These could cause serious side effects that could cause death. Before you take Rescriptor, you must tell your healthcare provider about all the medicines you are taking or are planning to take. These include other prescription and nonprescription medicines and herbal supplements.   For more information about medicines you should not take with Rescriptor, please read the section titled "MEDICINES YOU SHOULD NOT TAKE WITH Rescriptor." • Do not take Rescriptor if you have an allergy to Rescriptor. Also tell your healthcare provider if you have any known allergies to other medicines, foods, preservatives, or dyes. • Tell your healthcare provider if you are pregnant or plan to become pregnant. The effects of Rescriptor on pregnant women or their unborn babies are not known. • If you are breastfeeding, do not breastfeed. We do not know if Rescriptor 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. Talk with your healthcare provider about the best way to feed your baby. • Talk with your healthcare provider if you have liver or kidney disease. Rescriptor has not been studied in people with liver or kidney disease. • Certain medical problems may affect the use of Rescriptor. Be sure to tell your healthcare provider of any other medical problems you may have.

Can I take Rescriptor with other medicines?

Rescriptor may interact with other medicines, including those you take without a prescription. You must tell your healthcare provider about all medicines you are taking or planning to take before you take Rescriptor. It is a good idea to keep a complete list of all the medicines that you take, including nonprescription medicines, herbal remedies and supplements, and street drugs. Update this list when medicines are added or stopped. Give copies of this list to all of your healthcare providers every time you visit or fill a prescription.

MEDICINES YOU SHOULD NOT TAKE WITH Rescriptor

Do not take the following medicines with Rescriptor because they can cause serious problems or death if taken with Rescriptor:

• VERSED® (midazolam) Injection and Syrup (for sedation) • HALCION® (triazolam) Tablets (for sleep problems) • XANAX® (alprazolam) Tablets (for anxiety) • D.H.E. 45® Injection, ERGOMAR®, MIGRANAL®, WIGRAINE®, and CAFERGOT® (for migraine headaches) • METHERGINE® (for bleeding after childbirth) • ORAP® (pimozide) Tablets (for seizures) • PROPULSID® (cisapride) Tablets and Suspension (for heartburn) • HISMANAL® (astemizole) Tablets (for allergies) • SELDANE® (terfenadine) Tablets (for allergies)

Do not take the following medicines when you take Rescriptor. They may reduce the levels of Rescriptor in the blood and make it less effective. Talk with your healthcare provider if you are currently taking these medicines because other medicines may have to be given to take their place:

• Rifampin (also known as RIMACTANE®, RIFADIN®, RIFATER®, RIFAMATE®) (to treat tuberculosis) • Phenobarbital (for seizures) • DILANTIN® (phenytoin) (for seizures) • TEGRETOL® (carbamazepine) (for seizures)

Do not take Rescriptor with St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John's wort. Talk with your healthcare provider if you are taking or planning to take St. John's wort. Taking St. John's wort may decrease levels of Rescriptor and lead to increased viral load and possible resistance to Rescriptor or cross-resistance to other anti-HIV medicines.

Do not take Rescriptor with cholesterol-lowering medicines MEVACOR® (lovastatin) or ZOCOR® (simvastatin) because of possible serious reactions. There is also an increased risk of drug interactions between Rescriptor and LIPITOR® (atorvastatin), BAYCOL® (cerivastatin), and LESCOL® (fluvastatin); talk to your healthcare provider before you take any of these cholesterol-reducing medicines with Rescriptor.

Medicines that require dosage adjustments:

It is possible that your healthcare provider may need to increase or decrease the dose of other medicines when you are taking Rescriptor. Remember to tell your healthcare provider all the medicines you are taking or planning to take.

Before you take VIAGRA® (sildenafil) with Rescriptor, talk to your healthcare provider about problems these 2 medicines can cause when taken together. You may get increased side effects of VIAGRA, such as low blood pressure, vision changes, and penis erection lasting more than 4 hours. If an erection lasts longer than 4 hours, get medical help right away to avoid permanent damage to your penis. Your healthcare provider can explain these symptoms to you.

• If you are taking both VIDEX® (didanosine, ddI) and Rescriptor: Take VIDEX (buffered tablets) 1 hour before or 1 hour after you take Rescriptor. Taking them together causes lower amounts of Rescriptor in the blood, making both medicines less effective. • Protease inhibitors: A number of healthy volunteers and HIV-1-infected patients were studied while taking Rescriptor with one of these protease inhibitors: CRIXIVAN® (indinavir), INVIRASE® and FORTOVASE® (saquinavir), NORVIR® (ritonavir), or VIRACEPT® (nelfinavir). Rescriptor was shown to increase the amount of these protease inhibitors in the blood. Rescriptor is expected to increase the amount of AGENERASE® (amprenavir) and KALETRA® (lopinavir + ritonavir) in the blood. As a result, your healthcare provider may choose to lower the dose of one of these medicines or monitor certain lab tests if these protease inhibitors are taken in combination with Rescriptor. • Antacids should be taken at least 1 hour before or 1 hour after you take Rescriptor because they can slow the absorption of Rescriptor.

Based on your history of taking other anti-HIV medicine, your healthcare provider will direct you on how to take Rescriptor and other anti-HIV medicines. These drugs should be taken in a certain order or at specific times. This will depend on how many times a day each medicine should be taken. It will also depend on whether the medicines should be taken with or without food.

What are the possible side effects of Rescriptor?

• This list of side effects is not complete. If you have questions about side effects, ask your doctor, nurse, or pharmacist. You should report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects. • The most important common side effect seen in people taking Rescriptor has been a skin rash. The rash occurs mainly on the upper body and upper arms, and sometimes on the neck and face. The rash appears as a red area on the skin with slight bumps, and it can be itchy. The rash tends to occur early, usually within 1 to 3 weeks after you start taking Rescriptor, and it usually lasts less than 2 weeks. Watch your rash carefully and talk to your healthcare provider about how to treat it. If the rash is going to be serious or severe (with fever, blistering, sores in the mouth, redness or swelling of the eyes, or muscle and joint aches), you and your healthcare provider will usually realize it during the first 3 days of the rash. If you have symptoms of a severe rash, you should stop taking Rescriptor and speak with your healthcare provider as soon possible. Be prepared to explain where the rash is, your temperature, and whether or not you have other symptoms. • Other side effects include headache, nausea, diarrhea, and tiredness. Of these, nausea was the most common. • Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time. • Before you start using any medicine, talk with your healthcare provider about what to expect and discuss ways to reduce the side effects you may have.

How do I store Rescriptor?

• Keep Rescriptor and all other medicines out of the reach of children. Keep the bottle closed and store at room temperature (between 68°F and 77°F) away from sources of moisture such as a sink or other damp place. Heat and moisture may reduce the effectiveness of Rescriptor. • Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children.

General advice about prescription medicines:

Discuss all questions about your health with your healthcare provider. If you have questions about Rescriptor or any other medicines you are taking, ask your healthcare provider. You can also call 1-877-844-8872 toll free.

AGENERASE and Rescriptor are registered trademarks of ViiV Healthcare.

The brands listed are trademarks of their respective owners and are not trademarks of ViiV Healthcare. The makers of these brands are not affiliated with and do not endorse ViiV Healthcare or its products.

Manufactured for

ViiV Healthcare

Research Triangle Park, NC 27709

by

Pfizer Pharmaceuticals LLC

Vega Baja, Puerto Rico 00693

©2012, ViiV Healthcare. All rights reserved.

August 2012

RES: 3PIL

NDC 49702-209-24

Rescriptor®

delavirdine mesylate tablets

100 mg

360 Tablets

Rx only

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

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

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Keep container tightly closed. Protect from high humidity.

DOSAGE AND USE:

See prescribing information for dosage information.

Each tablet contains 100mg delavirdine mesylate.

Rev. 10/10

Manufactured for

ViiV Healthcare

Research Triangle Park, NC 27709

by

Pfizer Pharmaceuticals LLC

Vega Baja, Puerto Rico 00693

11342301