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Viramune XR

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Viramune XR

Viramune XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Viramune XR (nevirapine) is used an antiviral medication to treat HIV in adults. The most common side effect is rash. Viramune XR can cause serious side effects including fatal liver and skin problems. In general, women have a higher risk of liver problems compared to men.

The adult starting dose of Viramune XR with one 200 mg tablet, once daily for the first 14 days, followed by one 400 mg tablet of Viramune XR once daily. This regimen must be followed to reduce the frequency of rash. Viramune XR may interact with other drugs. Tell your doctor all medications you use. Viramune XR should be used during pregnancy only if the potential benefit justifies the potential risk of harm to the fetus. Severe events involving the liver, including fatalities, have been reported in pregnant women receiving chronic Viramune XR therapy. Viramune XR is excreted in breast milk. Because HIV can be transmitted in breast milk, do not breastfeed.

Our Viramune XR Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Viramune XR in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: tired feeling, joint or muscle pain, muscle weakness, skin rash, bruising, severe tingling, numbness, mouth sores, trouble breathing, or swelling of your face, lips, tongue, or throat.

Stop taking nevirapine and call your doctor at once if you have a serious side effect such as:

  • nausea, pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • any other signs of new infection; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, or stomach pain;
  • muscle pain;
  • headache, tired feeling; 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.

Read the entire detailed patient monograph for Viramune XR (Nevirapine Extended-Release Tablets, for Oral Use) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Viramune XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience In Adult Patients

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most serious adverse reactions associated with nevirapine are hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

The most common clinical toxicity of nevirapine is rash, which can be severe or life-threatening [see BOXED WARNING and WARNINGS AND PRECAUTIONS]. Rash occurs most frequently within the first 6 weeks of therapy. Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities.

The safety database in VIRAMUNE XR clinical trials contains data from 800 subjects treated with VIRAMUNE XR and 654 subjects treated with immediate release VIRAMUNE.

Trial 1100.1486 (VERxVE)

In Trial 1100.1486 (VERxVE) treatment-na´ve subjects received a lead-in dose of immediate-release VIRAMUNE 200 mg once daily for 14 days (n=1068) and then were randomized to receive either immediate-release VIRAMUNE 200 mg twice daily (n=506) or VIRAMUNE XR 400 mg once daily (n=505). All subjects received tenofovir + emtricitabine as background therapy. Subjects were enrolled with CD4+ counts less than 250 cells/mm³ for women and less than 400 cells/mm³ for men [see INDICATIONS AND USAGE]. Data on potential symptoms of hepatic events were prospectively collected in this trial. The safety data include all subject visits up to the time of the last subject's completion of the 96 week endpoint in the trial (mean observation period 98 weeks).

After the lead-in period, the incidence of any hepatic event was 9% in the immediate-release VIRAMUNE group and 6% in the VIRAMUNE XR group; the incidence of symptomatic hepatic events (anorexia, jaundice, vomiting) was 3% and 2%, respectively. The incidence of GRADE 3 or 4 ALT/AST elevation was 8% in both the immediate-release VIRAMUNE group and VIRAMUNE XR group. Overall, there was a comparable incidence of symptomatic hepatic events among men and women enrolled in VERxVE.

Severe or life-threatening rash considered to be related to nevirapine treatment occurred in 1% of subjects during the lead-in phase with immediate-release VIRAMUNE, and in 1% of subjects in either treatment group during the randomization phase. In addition, six cases of Stevens-Johnson syndrome were reported in the trial; all but one occurred within the first 30 days of nevirapine treatment.

No Grade 2 or above adverse reactions judged to be related to treatment by the investigator occurred in more than 2% of subjects during the 14-day lead-in with immediate-release VIRAMUNE (200 mg once daily), with the exception of rash which occurred in 4% of subjects.

Adverse reactions of at least moderate intensity (Grades 2 or above) 2% or more of treatment-na´ve subjects receiving either immediate-release VIRAMUNE or VIRAMUNE XR after randomization in Trial 1100.1486 are shown in Table 2.

Table 2 : Selected Clinical Adverse Drug Reactions* of at least Moderate Intensity (Grade 2 or above) Occurring in 2% or more of Adult Subjects- Week 96 Analysis of Trial 1100.14861

Adverse Drug Reaction VIRAMUNE Immediate-Release
N=506 (%)
VIRAMUNE XR
N=505 (%)
Rash2 4 5
Diarrhea 4 4
Headache 4 4
Clinical Hepatitis3 4 2
Abdominal Pain 2 3
Arthralgia 2 2
Pyrexia 2 1
Nausea 2 1
Fatigue 2 2
* Excludes laboratory abnormalities reported as ADRs
1Mean observation period 98 weeks.
2Rash includes terms rash, rash maculo-papular, erythema nodosum, rash erythematous, rash papular, skin reaction, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS).
3Clinical hepatitis includes terms hepatitis, hepatotoxicity, hepatitis acute, liver disorder, hepatitis toxic, hepatic failure, jaundice.

Laboratory Abnormalities

Liver enzyme test abnormalities (AST, ALT) were observed in subjects receiving VIRAMUNE XR. Asymptomatic elevations in GGT occur frequently but are not a contraindication to continue therapy with nevirapine in the absence of elevations in other liver enzyme tests. Laboratory abnormalities that occurred in trial 1100.1486 are shown in Table 3.

Table 3 : Grade 2 to Grade 4 Laboratory Abnormalities that Represent a Worsening from Baseline Observed in at least 5% of Subjects in Either Treatment Group - Trial 1100.1486

Laboratory Parameter (unit) Limit VIRAMUNE Immediate-Release (%) (N=506) VIRAMUNE XR (%) (N=505)
Chemistry
SGPT/ALT (U/L)
Grade 2 2.6-5.0 x ULN 13 10
Grade 3 5.1-10.0 x ULN 3 4
Grade 4 > 10.0 x ULN 4 2
SGOT/AST (U/L)
Grade 2 2.6-5.0 x ULN 9 7
Grade 3 5.1-10.0 x ULN 2 3
Grade 4 > 10.0 x ULN 2 2
Amylase (U/L)
Grade 2 1.6-2.0 x ULN 4 5
Grade 3 2.1-5.0 x ULN 4 2
Grade 4 > 5.0 x ULN 0 < 1
Phosphate (mg/dL)
Grade 2 2.0-2.4 x ULN 38 33
Grade 3 1.0-1.9 x ULN 6 7
Grade 4 < 1.0 x ULN < 1 0
Grade 2 1.6-2.0 x ULN 4 5
Grade 3 2.1-5.0 x ULN 4 2
Grade 4 > 5.0 x ULN 0 < 1
Hematology
Neutrophils
Grade 2 750-999/mm3 7 4
Grade 3 500-749/mm3 2 2
Grade 4 < 500/mm3 1 1
Lipids
LDL (mg/dL)
Grade 2 160-190 mg/dL 15 15
Grade 3 > 190 mg/dL 5 5
Cholesterol (mg/dL)
Grade 2 240-300 mg/dL 18 19
Grade 3 > 300 mg/dL 4 3

Trial 1100.1526 (TRANxITION)

In Trial 1100.1526 (TRANxITION) subjects on immediate-release VIRAMUNE 200 mg twice daily for at least 18 weeks were randomized to either receive VIRAMUNE XR 400 mg once daily (n=295) or remain on their immediate-release VIRAMUNE treatment (n=148). Adverse reactions observed for VIRAMUNE XR subjects (48 week analysis) were similar to those observed in trial 1100.1486, as displayed in Table 2.

Clinical Trial Experience In Pediatric Patients

Adverse reactions were assessed in Trial 1100.1518, an open-label, multiple-dose, non-randomized, cross-over trial to evaluate the safety and steady-state pharmacokinetic parameters of VIRAMUNE XR tablets in HIV-1-infected pediatric subjects 3 to less than 18 years of age. Safety was further examined in an optional extension phase of the trial. Forty subjects who completed the pharmacokinetic part of the trial were treated with VIRAMUNE XR once daily in combination with other antiretrovirals for a median duration of 33 weeks. The most frequently reported adverse reactions related to VIRAMUNE XR in pediatric subjects were similar to those observed in adults. In pediatric subjects the incidence of Grade 2 or higher drug-related rash was 1%. There were no adverse reactions of Grade 2 or above which were considered to be related to treatment by the investigator that occurred in more than 1% of subjects [see Use In Specific Populations, CLINICAL PHARMACOLOGY, and Clinical Studies].

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of immediate-release VIRAMUNE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: fever, somnolence, drug withdrawal [see DRUG INTERACTIONS], redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS]

Gastrointestinal: vomiting

Liver and Biliary: jaundice, fulminant and cholestatic hepatitis, hepatic necrosis, hepatic failure

Hematology: anemia, eosinophilia, neutropenia

Investigations: decreased serum phosphorus

Musculoskeletal: arthralgia, rhabdomyolysis associated with skin and/or liver reactions

Neurologic: paraesthesia

Skin and Appendages: allergic reactions including anaphylaxis, angioedema, bullous eruptions, ulcerative stomatitis and urticaria have all been reported. In addition, hypersensitivity syndrome and hypersensitivity reactions with rash associated with constitutional findings such as fever, blistering, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise, fatigue, or significant hepatic abnormalities [see WARNINGS AND PRECAUTIONS] plus one or more of the following: hepatitis, eosinophilia, granulocytopenia, lymphadenopathy, and/or renal dysfunction have been reported.

Read the entire FDA prescribing information for Viramune XR (Nevirapine Extended-Release Tablets, for Oral Use) »

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