Etravirine

ETRAVIRINE- etravirine tablet
Amneal Pharmaceuticals NY LLC

1 INDICATIONS AND USAGE

Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 6 years of age and older [see Microbiology (12.4) and Clinical Studies (14)].

Additional pediatric use information is approved for Janssen Products, LP’s INTELENCE® (etravirine) tablets. However, due to Janssen Products, LP’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adult Patients

The recommended oral dosage of etravirine tablets for adult patients is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The type of food does not affect the exposure to etravirine [see Clinical Pharmacology (12.3)].

2.2 Recommended Dosage During Pregnancy

The recommended oral dosage of etravirine tablets for pregnant individuals is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Use in Specific Populations (8.1)].

2.3 Recommended Dosage in Pediatric Patients (6 Years to Less Than 18 Years of Age)

The recommended dosage of etravirine tablets for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see Table 1) not exceeding the recommended adult dosage. Etravirine tablets should be taken orally, following a meal. The type of food does not affect the exposure to etravirine tablets [see Clinical Pharmacology (12.3)].

Table 1: Recommended Dosage of Etravirine Tablets for Pediatric Patients 6 Years to Less Than 18 Years of Age

Body Weight

kilograms (kg)

Dose

greater than or equal to 16 kg to less than 20 kg

100 mg twice daily

greater than or equal to 20 kg to less than 25 kg

125 mg twice daily

greater than or equal to 25 kg to less than 30 kg

150 mg twice daily

greater than or equal to 30 kg

200 mg twice daily

Additional pediatric use information is approved for Janssen Products, LP’s INTELENCE® (etravirine) tablets. However, due to Janssen Products, LP’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.4 Method of Administration

Instruct patients to swallow the etravirine tablet(s) whole with liquid such as water. Patients who are unable to swallow the etravirine tablet(s) whole may disperse the tablet(s) in water. Instruct the patient to do the following:

  • place the tablet(s) in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication,
  • stir well until the water looks milky,
  • add approximately 15 mL (1 tablespoon) of liquid. Water may be used but other liquids, such as orange juice or milk, may improve taste. Patients should not place the tablets in orange juice or milk without first adding water. The use of warm (temperature greater than 104°F [greater than 40°C]) or carbonated beverages should be avoided.
  • drink the mixture immediately,
  • rinse the glass several times with orange juice, milk or water and completely swallow the rinse each time to make sure the patient takes the entire dose.

3 DOSAGE FORMS AND STRENGTHS

  • 25 mg white to off-white, oval shaped, uncoated tablets debossed with “A56” on one side and score on the other side.
  • 100 mg white to off-white oval shaped, uncoated tablets debossed with “AC75” on one side and plain on the other side.
  • 200 mg white to off-white, oval shaped, uncoated tablets debossed with “AC76” on one side and plain on the other side.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Severe Skin and Hypersensitivity Reactions

Severe, potentially life-threatening and fatal skin reactions have been reported. In clinical trials, these include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In Phase 3 clinical trials, Grade 3 and 4 rashes were reported in 1.3% of subjects receiving etravirine compared to 0.2% of placebo subjects. A total of 2.2% of HIV-1-infected subjects receiving etravirine discontinued from Phase 3 trials due to rash [see Adverse Reactions (6.1)]. Rash occurred most commonly during the first 6 weeks of therapy. The incidence of rash was higher in females [see Adverse Reactions (6.1)]. Stevens-Johnson syndrome was reported in 1.1% (2/177) of pediatric patients less than 18 years of age receiving etravirine in combination with other HIV-1 antiretroviral agents in an observational study.

Discontinue etravirine immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver transaminases should be monitored and appropriate therapy initiated. Delay in stopping etravirine treatment after the onset of severe rash may result in a life-threatening reaction.

5.2 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions

The concomitant use of etravirine and other drugs may result in potentially significant drug interactions, some of which may lead to [see Drug Interactions (7.3)]:

  • Loss of therapeutic effect of concomitant drug or etravirine and possible development of resistance.
  • Possible clinically significant adverse reactions from greater exposures of etravirine or other concomitant drugs.

See Table 4 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during etravirine therapy and review concomitant medications during etravirine therapy.

5.3 Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including etravirine. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia (PCP) or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

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