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Nevirapine 200 mg Tablet, 60-count — NDC 65162-0209-06 package photo

Nevirapine 200 mg Tablet, 60-count

by Amneal Pharmaceuticals LLC · 60 TABLET in 1 BOTTLE (65162-209-06)
NDC 65162-0209-06
🏷️ FDA NDC (as labeled) 65162-209-06 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 65162-209-06
Product NDC 65162-209
11-digit billing NDC 65162020906
NCPDP billing unit EA — each (per item)
RxCUI 199422
UNII 99DK7FVK1H
UPC 0365162209068
Application # ANDA078195
SPL Set ID 4f065674-4719-4c79-ba0d-549040d77f17
Established class (EPC) Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of action Non-Nucleoside Reverse Transcriptase Inhibitors; Cytochrome P450 3A Inducers; Cytochrome P450 2B6 Inducers
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-04-30
Route ORAL
Dosage form TABLET
Substance NEVIRAPINE
GCN Seq No 027467
GCN 31420
HICL code 011592
Ingredient (HICL) Nevirapine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5K
Therapeutic class — specific (HIC3) Antivirals, Hiv-Specific, Non-Nucleoside, Rti
AHFS code 08:18.08.16
AHFS class Hiv Nonnucleoside Rev.transcrip. Inhib.
FDB label name NEVIRAPINE 200 MG TABLET
FDB brand name Nevirapine
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65162-209-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65162-0209-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Non-nucleoside reverse transcriptase inhibitors
How it works Non-Nucleoside Reverse Transcriptase Inhibitors, Cytochrome P450 2B6 Inducers, Cytochrome P450 3A Inducers
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderSTRIDES PHARMA GLOBAL PTE LTD
FDA applicationANDA078195 (ANDA)
Labeler code65162
First marketedApr 2014
Product typeHuman Prescription Drug
Portfolio490 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NEVIRAPINE 200 MG TABLET Ingredient Nevirapine
📖 What it is MedlinePlus · NLM

Nevirapine is used to treat human immunodeficiency virus (HIV) infection. Nevirapine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood. Although nevirapine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other life-style changes may decrease the risk of giving the HIV virus to other people.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Nevirapine doesn't cure HIV, but it helps control it. It works by blocking an enzyme the HIV virus needs to make copies of itself. When you take it alongside your other HIV medicat...
  • What exactly does nevirapine do — does it cure HIV?
  • That 14-day lead-in period at a lower once-daily dose is actually a safety step built into how nevirapine is prescribed. Clinical evidence shows it significantly reduces the chance...
  • Why do I have to start at a lower dose for the first two weeks?
📖 Read our full Nevirapine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeOval
ImprintN;2
Size16 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2869 $17.21 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nevirapine 200 mg 00378-4050-91 Mylan 60 tablets $0.147 AB Availability likely —
Nevirapine 200 mg 33342-0004-09 Macleods 60 tablets $0.147 AB Availability likely —
Nevirapine 200 mg 31722-0505-01 Camber 100 tablets — AB FDA listed —
Nevirapine 200 mg 42571-0131-29 Micro 60 tablets — AB FDA listed —
Nevirapine 200 mgthis 65162-0209-06 Amneal 60 tablets — — FDA listed —
Nevirapine 200 mg 65862-0027-10 Aurobindo 60 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2014
On the market since
Apr 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nevirapine — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nevirapine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$55K
Claims incl. refills
1K
Beneficiaries
628
Spend / beneficiary
$87.61
Spend / claim
$53.63
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65162-0209-06 You're viewing this 60 TABLET in 1 BOTTLE (65162-209-06) 2014-04-30 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65162-209-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65162-0209-06, written without dashes as 65162020906. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65162-0209-06, the first segment (65162) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0209) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS HEPATOTOXICITY: Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with Nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash.

Female gender and higher CD4 + cell counts at initiation of therapy place patients at increased risk; women with CD4 + cell counts greater than 250 cells/mm 3 , including pregnant women receiving Nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with Nevirapine use can occur in both genders, all CD4 + cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking Nevirapine for post-exposure prophylaxis (PEP).

Use of Nevirapine for occupational and non-occupational PEP is contraindicated [ see Contraindications (4.2) ]. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue Nevirapine and seek medical evaluation immediately [ see Warnings and Precautions (5.1) ]. SKIN REACTIONS: Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with Nevirapine.

These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue Nevirapine and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment.

The 14-day lead-in period with Nevirapine 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed [ see Warnings and Precautions (5.2) ]. MONITORING: Patients must be monitored intensively during the first 18 weeks of therapy with Nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events.

Do not restart Nevirapine following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment. WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS See full prescribing information for complete boxed warning.

Fatal and non-fatal hepatotoxicity (5.1) Fatal and non-fatal skin reactions (5.2) Discontinue immediately if experiencing: Signs or symptoms of hepatitis (5.1) Increased transaminases combined with rash or other systemic symptoms (5.1) Severe skin or hypersensitivity reactions (5.2) Any rash with systemic symptoms (5.2) Monitoring during the first 18 weeks of therapy is essential. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events (5) .

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Nevirapine tablets, USP are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial (BI 1090) that demonstrated prolonged suppression of HIV-1 RNA and two smaller supportive trials, one of which (BI 1046) is described below. Additional important information regarding the use of Nevirapine tablets, USP for the treatment of HIV-1 infection: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP should not be initiated in adult females with CD4 + cell counts greater than 250 cells/mm 3 or in adult males with CD4 + cell counts greater than 400 cells/mm 3 unless the benefit outweighs the risk [ see Boxed Warning and Warnings and Precautions (5.1) ].

The 14-day lead-in period with Nevirapine tablets, USP 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [ see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ]. If rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily. The 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought.

Nevirapine tablets, USP are an NNRTI indicated for combination antiretroviral treatment of HIV-1 infection (1) Important Considerations: Initiation of treatment is not recommended in the following populations unless the benefits outweigh the risks (1, 5.1) adult females with CD4 + cell counts greater than 250 cells/mm 3 adult males with CD4 + cell counts greater than 400 cells/mm 3 The 14-day lead-in period must be strictly followed; it has been demonstrated to reduce the frequency of rash (2.4, 5.2)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION If any patient experiences rash during the 14-day lead-in period, do not increase dose until the rash has resolved. Do not continue the lead-in dosing regimen beyond 28 days (2.4) If dosing interrupted for greater than 7 days, restart 14-day lead-in dosing (2.4) Adults (≥16 yrs) Pediatric* (>15 days) First 14 days 200 mg once daily 150 mg/m 2 once daily After 14 days 200 mg twice daily 150 mg/m 2 twice daily *Total daily dose should not exceed 400 mg for any patient.

2.1Adults The recommended dose for Nevirapine tablets, USP is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.

2.2Pediatric Patients The recommended oral dose for pediatric patients 15 days and older is 150 mg/m 2 once daily for 14 days followed by 150 mg/m 2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient. Mosteller Formula

2.3Monitoring of Patients Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with Nevirapine tablets, USP. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation.

After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout Nevirapine tablets, USP treatment [ see Warnings and Precautions (5) ]. In some cases, hepatic injury has progressed despite discontinuation of treatment.

2.4Dosage Adjustment Patients with Rash Discontinue Nevirapine tablets, USP if a patient experiences severe rash or any rash accompanied by constitutional findings [ see Boxed Warning , Warnings and Precautions (5.2) , and Patient Counseling Information (17.1) ]. Do not increase Nevirapine tablets, USP dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m 2 /day in pediatric patients) until the rash has resolved [ see Warnings and Precautions (5.2) and Patient Counseling Information (17.1) ].

The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought. Patients with Hepatic Events If a clinical (symptomatic) hepatic event occurs, permanently discontinue Nevirapine tablets, USP. Do not restart Nevirapine tablets, USP after recovery [ see Warnings and Precautions (5.1) ].

Patients with Dose Interruption For patients who interrupt Nevirapine tablets, USP dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m 2 /day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m 2 twice daily for pediatric patients). Patients with Renal Impairment Patients with CrCL greater than or equal to 20 mL/min do not require an adjustment in Nevirapine tablets, USP dosing. An additional 200 mg dose of Nevirapine tablets, USP following each dialysis treatment is indicated in patients requiring dialysis.

Nevirapine tablets, USP metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [ see Clinical Pharmacology (12.3) ].

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 200 mg, White to off-white oval shaped tablets engraved “N2” with a single bisect separating ‘N’ and ‘2’ on one side and plain on the other side. Tablets: 200 mg (3)

⛔ Contraindications 94 words ▾

4 CONTRAINDICATIONS Patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment (4.1, 5.1, 8.7) Use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens, an unapproved use (4.2, 5.1)

4.1Hepatic Impairment Nevirapine, USP is contraindicated in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [ see Warnings and Precautions (5.1) and Use in Specific Populations (8.7) ].

4.2Post-Exposure Prophylaxis Nevirapine, USP is contraindicated for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [ see Warnings and Precautions (5.1) ].

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS 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 associated with signs of hypersensitivity which can 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. The first 18 weeks of therapy with Nevirapine are a critical period during which intensive clinical and laboratory monitoring of patients is required to detect potentially life-threatening hepatic events and skin reactions.

The optimal frequency of monitoring during this time period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, include monitoring of liver enzyme tests at baseline, prior to dose escalation and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout Nevirapine treatment.

In addition, the 14-day lead-in period with Nevirapine 200 mg daily dosing has been demonstrated to reduce the frequency of rash [ see Dosage and Administration (2.1) ]. Hepatotoxicity: Fatal and non-fatal hepatotoxicity has been reported. Monitor liver function tests before and during therapy.

Permanently discontinue nevirapine if clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms occur. Do not restart nevirapine after recovery. (5.1) Rash: Fatal and non-fatal skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions, have been reported.

Permanently discontinue nevirapine if severe skin reactions or hypersensitivity reactins occur. Check transaminase immediately for all patients who develop a rash in the first 18 weeks of treatment. (5.2) Monitor patients for immune reconstitution syndrome and fat redistribution (5.5, 5.6) .

5.1Hepatotoxicity and Hepatic Impairment Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, have been reported in patients treated with Nevirapine. In controlled clinical trials, symptomatic hepatic events regardless of severity occurred in 4% (range 0% to 11%) of subjects who received Nevirapine and 1% of subjects in control groups. The risk of symptomatic hepatic events regardless of severity was greatest in the first 6 weeks of therapy.

The risk continued to be greater in the Nevirapine groups compared to controls through 18 weeks of treatment. However, hepatic events may occur at any time during treatment. In some cases, subjects presented with non-specific, prodromal signs or symptoms of fatigue, malaise, anorexia, nausea, jaundice, liver tenderness or hepatomegaly, with or without initially abnormal serum transaminase levels.

Rash was observed in approximately half of the subjects with symptomatic hepatic adverse events. Fever and flu-like symptoms accompanied some of these hepatic events. Some events, particularly those with rash and other symptoms, have progressed to hepatic failure with transaminase elevation, with or without hyperbilirubinemia, hepatic encephalopathy, prolonged partial thromboplastin time, or eosinophilia.

Rhabdomyolysis has been observed in some patients experiencing skin and/or liver reactions associated with Nevirapine use. Patients with signs or symptoms of hepatitis must be advised to discontinue Nevirapine and immediately seek medical evaluation, which should include liver enzyme tests. Transaminases should be checked immediately if a patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity reaction.

Transaminases should also be checked immediately for all patients who develop a rash in the first…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reaction is rash. In adults the incidence of rash is 15% vs 6% with placebo, with Grade 3/4 rash occurring in 2% of subjects (6.1) In pediatric subjects the incidence of rash (all causality) was 21% (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or www.amneal.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials in Adults 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 (5.1, 5.2) ].

Hepatic Reaction In controlled clinical trials, symptomatic hepatic events regardless of severity occurred in 4% (range 0% to 11%) of subjects who received Nevirapine and 1% of subjects in control groups. Female gender and higher CD4 + cell counts (greater than 250 cells/mm 3 in women and greater than 400 cells/mm 3 in men) place patients at increased risk of these events [ see Boxed Warning and Warnings and Precautions (5.1) ]. Asymptomatic transaminase elevations (AST or ALT greater than 5X ULN) were observed in 6% (range 0% to 9%) of subjects who received Nevirapine and 6% of subjects in control groups.

Co-infection with hepatitis B or C and/or increased transaminase elevations at the start of therapy with Nevirapine are associated with a greater risk of later symptomatic events (6 weeks or more after starting Nevirapine) and asymptomatic increases in AST or ALT. Liver enzyme abnormalities (AST, ALT, GGT) were observed more frequently in subjects receiving Nevirapine than in controls (see Table 3). Skin Reaction The most common clinical toxicity of Nevirapine is rash, which can be severe or life-threatening [ see Boxed Warning and Warnings and Precautions (5.2) ].

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. In controlled clinical trials (Trials 1037, 1038, 1046, and 1090), Grade 1 and 2 rashes were reported in 13% of subjects receiving Nevirapine compared to 6% receiving placebo during the first 6 weeks of therapy.

Grade 3 and 4 rashes were reported in 2% of Nevirapine recipients compared to less than 1% of subjects receiving placebo. Women tend to be at higher risk for development of Nevirapine-associated rash [ see Boxed Warning and Warnings and Precautions (5.2) ]. Treatment-related, adverse experiences of moderate or severe intensity observed in greater than 2% of subjects receiving Nevirapine in placebo-controlled trials are shown in Table 2.

Table 2 Percentage of Subjects with Moderate or Severe Drug-Related Events in Adult Placebo-Controlled Trials Trial 1090 1 Trials 1037, 1038, 1046 2 Nevirapine Placebo Nevirapine Placebo (n=1121) (n=1128) (n=253) (n=203) Median exposure (weeks) 58 52 28 28 Any adverse event 15% 11% 32% 13% Rash 5 2 7 2 Nausea 1 1 9 4 Granulocytopenia 2 3 <1 0 Headache 1 <1 4 1 Fatigue <1 <1 5 4 Diarrhea <1 1 2 1 Abdominal pain <1 <1 2 0 Myalgia <1 0 1 2 1 Background therapy included 3TC for all subjects and combinations of NRTIs and PIs.

Subjects had CD4 + cell counts less than 200 cells/mm 3 . 2 Background therapy included ZDV and ZDV+ddI; Nevirapine monotherapy was administere…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Nevirapine is principally metabolized by the liver via the cytochrome P450 isoenzymes, 3A and 2B6. Nevirapine is known to be an inducer of these enzymes. As a result, drugs that are metabolized by these enzyme systems may have lower than expected plasma levels when co-administered with nevirapine.

The specific pharmacokinetic changes that occur with co-administration of nevirapine and other drugs are listed in Clinical Pharmacology , Table 5. Clinical comments about possible dosage modifications based on established drug interactions are listed in Table 4. The data in Tables 4 and 5 are based on the results of drug interaction trials conducted in HIV-1 seropositive subjects unless otherwise indicated.

In addition to established drug interactions, there may be potential pharmacokinetic interactions between Nevirapine and other drug classes that are metabolized by the cytochrome P450 system. These potential drug interactions are also listed in Table 4. Although specific drug interaction trials in HIV-1 seropositive subjects have not been conducted for some classes of drugs listed in Table 4, additional clinical monitoring may be warranted when co-administering these drugs.

The in vitro interaction between nevirapine and the antithrombotic agent warfarin is complex. As a result, when giving these drugs concomitantly, plasma warfarin levels may change with the potential for increases in coagulation time. When warfarin is co-administered with nevirapine, anticoagulation levels should be monitored frequently.

Table 4 Established and Potential Drug Interactions: Use With Caution, Alteration in Dose or Regimen May Be Needed Due to Drug Interaction Established Drug Interactions: See Clinical Pharmacology (12.3) , Table 5 for Magnitude of Interaction. Drug Name Effect on concentration of Nevirapine or Concomitant drug Clinical Comment Atazanavir/Ritonavir ↓ Atazanavir ↑ Nevirapine Do not co-administer nevirapine with atazanavir because nevirapine substantially decreases atazanavir exposure. Clarithromycin ↓ Clarithromycin ↑ 14-OH clarithromycin Clarithromycin exposure was significantly decreased by nevirapine; however, 14-OH metabolite concentrations were increased.

Because clarithromycin active metabolite has reduced activity against Mycobacterium avium- intracellulare complex , overall activity against this pathogen may be altered. Alternatives to clarithromycin, such as azithromycin, should be considered. Efavirenz ↓ Efavirenz There has been no determination of appropriate doses for the safe and effective use of this combination [ see Warnings and Precautions (5.4) ].

Ethinyl estradiol and Norethindrone ↓ Ethinyl estradiol ↓ Norethindrone Oral contraceptives and other hormonal methods of birth control should not be used as the sole method of contraception in women taking nevirapine, since nevirapine may lower the plasma levels of these medications. An alternative or additional method of contraception is recommended Fluconazole ↑Nevirapine Because of the risk of increased exposure to nevirapine, caution should be used in concomitant administration, and patients should be monitored closely for nevirapine- associated adverse events.

Fosamprenavir ↓Amprenavir ↑Nevirapine Co-administration of nevirapine and fosamprenavir without ritonavir is not recommended. Fosamprenavir/Ritonavir ↓Amprenavir ↑Nevirapine No dosing adjustments are required when nevirapine is co-administered with 700/100 mg of fosamprenavir/ritonavir twice daily. Indinavir ↓ Indinavir Appropriate doses for this combination are not established, but an increase in the dosage of indinavir may be required.

Ketoconazole ↓ Ketoconazole Nevirapine and ketoconazole should not be administered concomitantly because decreases in ketoconazole plasma concentrations may reduce the efficacy of the drug. Lopinavir/Ritonavir ↓Lopinavir A dose increase of lopinavir/ritonavir tablets to 500/125 mg twice-daily is recommended when used in combination with nevirapine. A dose…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Monitor patients with hepatic fibrosis or cirrhosis carefully for evidence of drug induced toxicity. Do not administer Nevirapine to patients with Child-Pugh B or C (5.1, 8.7) No dose adjustment is required for patients with renal impairment. Patients on dialysis receive an additional dose of 200 mg following each dialysis treatment (8.6) Antiretroviral Pregnancy Registry available (8.1)

8.1Pregnancy Teratogenic Effects, Pregnancy Category B. No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits. The maternal and developmental no-observable-effect level dosages produced systemic exposures approximately equivalent to or approximately 50% higher in rats and rabbits, respectively, than those seen at the recommended daily human dose (based on AUC).

In rats, decreased fetal body weights were observed due to administration of a maternally toxic dose (exposures approximately 50% higher than that seen at the recommended human clinical dose). There are no adequate and well-controlled trials of Nevirapine in pregnant women. The Antiretroviral Pregnancy Registry, which has been surveying pregnancy outcomes since January 1989, has not found an increased risk of birth defects following first trimester exposures to nevirapine.

The prevalence of birth defects after any trimester exposure to nevirapine is comparable to the prevalence observed in the general population. Severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic Nevirapine therapy as part of combination treatment of HIV-1 infection. Regardless of pregnancy status, women with CD4 + cell counts greater than 250 cells/mm 3 should not initiate Nevirapine unless the benefit outweighs the risk.

It is unclear if pregnancy augments the risk observed in non-pregnant women [ see Boxed Warning ]. Nevirapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Antiretroviral Pregnancy Registry To monitor maternal-fetal outcomes of pregnant women exposed to Nevirapine, an Antiretroviral Pregnancy Registry has been established.

Physicians are encouraged to register patients by calling 1-800-258-4263.

8.3Nursing Mothers The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Nevirapine is excreted in breast milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving Nevirapine.

8.4Pediatric Use The safety, pharmacokinetic profile, and virologic and immunologic responses of Nevirapine have been evaluated in HIV-1 infected pediatric subjects age 3 months to 18 years [ see A dverse Reactions (6.2) and Clinical Studies (14.2) ]. The safety and pharmacokinetic profile of Nevirapine has been evaluated in HIV-1 infected pediatric subjects age 15 days to less than 3 months [ see Adverse Reactions (6.2) and Clinical Studies (14.2) ]. The most frequently reported adverse events related to Nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and Nevirapine [ see Adverse Reactions (6.2) and Clinical Studies (14.2) ].

8.5Geriatric Use Clinical trials of Nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

8.6Renal Impairment In subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. Ne…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Teratogenic Effects, Pregnancy Category B. No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits. The maternal and developmental no-observable-effect level dosages produced systemic exposures approximately equivalent to or approximately 50% higher in rats and rabbits, respectively, than those seen at the recommended daily human dose (based on AUC).

In rats, decreased fetal body weights were observed due to administration of a maternally toxic dose (exposures approximately 50% higher than that seen at the recommended human clinical dose). There are no adequate and well-controlled trials of Nevirapine in pregnant women. The Antiretroviral Pregnancy Registry, which has been surveying pregnancy outcomes since January 1989, has not found an increased risk of birth defects following first trimester exposures to nevirapine.

The prevalence of birth defects after any trimester exposure to nevirapine is comparable to the prevalence observed in the general population. Severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic Nevirapine therapy as part of combination treatment of HIV-1 infection. Regardless of pregnancy status, women with CD4 + cell counts greater than 250 cells/mm 3 should not initiate Nevirapine unless the benefit outweighs the risk.

It is unclear if pregnancy augments the risk observed in non-pregnant women [ see Boxed Warning ]. Nevirapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Antiretroviral Pregnancy Registry To monitor maternal-fetal outcomes of pregnant women exposed to Nevirapine, an Antiretroviral Pregnancy Registry has been established.

Physicians are encouraged to register patients by calling 1-800-258-4263.

🧒 Pediatric Use 118 words ▾

8.4Pediatric Use The safety, pharmacokinetic profile, and virologic and immunologic responses of Nevirapine have been evaluated in HIV-1 infected pediatric subjects age 3 months to 18 years [ see A dverse Reactions (6.2) and Clinical Studies (14.2) ]. The safety and pharmacokinetic profile of Nevirapine has been evaluated in HIV-1 infected pediatric subjects age 15 days to less than 3 months [ see Adverse Reactions (6.2) and Clinical Studies (14.2) ]. The most frequently reported adverse events related to Nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and Nevirapine [ see Adverse Reactions (6.2) and Clinical Studies (14.2) ].

🧓 Geriatric Use 58 words ▾

8.5Geriatric Use Clinical trials of Nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 60 words ▾

10 OVERDOSAGE There is no known antidote for Nevirapine overdosage. Cases of Nevirapine overdose at doses ranging from 800 to 1800 mg per day for up to 15 days have been reported. Patients have experienced events including edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting and weight decrease. All events subsided following discontinuation of Nevirapine.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nevirapine is an antiviral drug [ see Clinical Pharmacology (12.4) ].

12.3Pharmacokinetics Adults Absorption and Bioavailability Nevirapine is readily absorbed (greater than 90%) after oral administration in healthy volunteers and in adults with HIV-1 infection. Absolute bioavailability in 12 healthy adults following single-dose administration was 93 ± 9% (mean ± SD) for a 50 mg tablet and 91 ± 8% for an oral solution. Peak plasma nevirapine concentrations of 2 ± 0.4 mcg/mL (7.5 micromolar) were attained by 4 hours following a single 200 mg dose.

Following multiple doses, nevirapine peak concentrations appear to increase linearly in the dose range of 200 to 400 mg/day. Steady-state trough nevirapine concentrations of 4.5 ± 1.9 mcg/mL (17 ± 7 micromolar), (n = 242) were attained at 400 mg/day. Nevirapine tablets have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg.

When Nevirapine (200 mg) was administered to 24 healthy adults (12 female, 12 male), with either a high-fat breakfast (857 kcal, 50 g fat, 53% of calories from fat) or antacid (Maalox ® 30 mL), the extent of nevirapine absorption (AUC) was comparable to that observed under fasting conditions. In a separate trial in HIV-1 infected subjects (n=6), nevirapine steady-state systemic exposure (AUCτ) was not significantly altered by didanosine, which is formulated with an alkaline buffering agent. Nevirapine may be administered with or without food, antacid or didanosine.

Distribution Nevirapine is highly lipophilic and is essentially nonionized at physiologic pH. Following intravenous administration to healthy adults, the apparent volume of distribution (Vdss) of nevirapine was 1.21 ±

0.09L/kg, suggesting that nevirapine is widely distributed in humans. Nevirapine readily crosses the placenta and is also found in breast milk [ see Use in Specific Populations (8.3) ]. Nevirapine is about 60% bound to plasma proteins in the plasma concentration range of 1 to 10 mcg/mL.

Nevirapine concentrations in human cerebrospinal fluid (n=6) were 45% (± 5%) of the concentrations in plasma; this ratio is approximately equal to the fraction not bound to plasma protein. Metabolism/Elimination In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytochrome P450 (oxidative) metabolism to several hydroxylated metabolites. In vitro studies with human liver microsomes suggest that oxidative metabolism of nevirapine is mediated primarily by cytochrome P450 (CYP) isozymes from the CYP3A and CYP2B6 families, although other isozymes may have a secondary role.

In a mass balance/excretion trial in eight healthy male volunteers dosed to steady-state with nevirapine 200 mg given twice daily followed by a single 50 mg dose of 14 C-nevirapine, approximately 91.4 ± 10.5% of the radiolabeled dose was recovered, with urine (81.3 ± 11.1%) representing the primary route of excretion compared to feces (10.1 ± 1.5%). Greater than 80% of the radioactivity in urine was made up of glucuronide conjugates of hydroxylated metabolites. Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.

Only a small fraction (less than 5%) of the radioactivity in urine (representing less than 3% of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound. Nevirapine is an inducer of hepatic cytochrome P450 (CYP) metabolic enzymes 3A and 2B6. Nevirapine induces CYP3A and CYP2B6 by approximately 20% to 25%, as indicated by erythromycin breath test results and urine metabolites.

Autoinduction of CYP3A and CYP2B6 mediated metabolism leads to an approximately 1.5- to 2-fold increase in the apparent oral clearance of nevirapine as treatment continues from a s…

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Nevirapine is an antiviral drug [ see Clinical Pharmacology (12.4) ].

📦 How Supplied / Storage and Handling 69 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Nevirapine Tablets, USP, 200 mg , are supplied as white to off-white oval shaped tablets engraved “N2” with a single bisect separating ‘N’ and ‘2’ on one side and plain on the other side. They are available as follows: Bottles of 60 NDC 65162-209-06 Storage Store below 30 ° C. Protect from light. Store in a safe place out of the reach of children.

📋 Description 113 words ▾

11 DESCRIPTION Nevirapine, USP is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine, USP is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3, 2-b:2",3"-e] [1,4] diazepin-6-one.

Nevirapine, USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C 15 H 14 N 4 O. Nevirapine, USP has the following structural formula: Nevirapine Tablets, USP are for oral administration. Each tablet contains 200 mg of nevirapine and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone, colloidal silicon dioxide and magnesium stearate, talc and croscarmellose sodium.

Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved Patient Labeling (Medication Guide) The Medication Guide provides written information for the patient, and should be dispensed with each new prescription and refill. A Medication Guide is supplied as a tear-off following the full prescribing information. ATTENTION PHARMACISTS: Detach “Medication Guide” and dispense with the product .

17.1Hepatotoxicity and Skin Reactions Inform patients of the possibility of severe liver disease or skin reactions associated with Nevirapine that may result in death. Instruct patients developing signs or symptoms of liver disease or severe skin reactions to discontinue Nevirapine and seek medical attention immediately, including performance of laboratory monitoring. Symptoms of liver disease include fatigue, malaise, anorexia, nausea, jaundice, acholic stools, liver tenderness or hepatomegaly.

Symptoms of severe skin or hypersensitivity reactions include rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, and/or hepatitis. Intensive clinical and laboratory monitoring, including liver enzymes, is essential during the first 18 weeks of therapy with Nevirapine to detect potentially life-threatening hepatotoxicity and skin reactions. However, liver disease can occur after this period; therefore, monitoring should continue at frequent intervals throughout Nevirapine treatment.

Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of hepatic events and skin reactions. Advise patients with signs and symptoms of hepatitis to discontinue Nevirapine and seek medical evaluation immediately. If Nevirapine is discontinued due to hepatotoxicity, do not restart it.

Patients, particularly women, with increased CD4 + cell count at initiation of Nevirapine therapy (greater than 250 cells/mm 3 in women and greater than 400 cells/mm 3 in men) are at substantially higher risk for development of symptomatic hepatic events, often associated with rash. Advice patients that co-infection with hepatitis B or C and/or increased transaminases at the start of therapy with Nevirapine are associated with a greater risk of later symptomatic events (6 weeks or more after starting Nevirapine) and asymptomatic increases in AST or ALT [ see Boxed Warning and Warnings and Precautions (5.1) ].

The majority of rashes associated with Nevirapine occur within the first 6 weeks of initiation of therapy. Instruct patients that if any rash occurs during the two-week lead-in period, do not escalate the Nevirapine dose until the rash resolves. The total duration of the once-daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen may need to be started.

Any patient experiencing a rash should have their liver enzymes (AST, ALT) evaluated immediately. Patients with severe rash or hypersensitivity reactions should discontinue Nevirapine immediately and consult a physician. Nevirapine should not be restarted following severe skin rash or hypersensitivity reaction.

Women tend to be at higher risk for development of Nevirapine-associated rash [ see Boxed Warning and Warnings and Precautions (5.2) ].

17.2Administration Inform patients to take Nevirapine every day as prescribed. Patients should not alter the dose without consulting their doctor. If a dose is missed, patients should take the next dose as soon as possible.

However, if a dose is skipped, the patient should not double the next dose. Advise patients to report to their doctor the use of any other medications. Inform patients that it is not known whether Nevirapine therapy reduces the risk of transmission of HIV-1 to others through sexual contact.

Effective treatment combined with safer sex practices may reduce the chance of passing HIV to others through sexual contact. Patients should be advised to continue to practice safer sex and to use latex or polyurethane condoms to lower…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Nevirapine Tablets Read this Medication Guide before you start taking Nevirapine and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Nevirapine? Nevirapine can cause serious side effects. These include severe liver and skin problems that can cause death.

These problems can happen at any time during treatment, but your risk is highest during the first 18 weeks of treatment. 1. Severe liver problems: Anyone who takes Nevirapine may get severe liver problems.

In some cases these liver problems can lead to liver failure and the need for a liver transplant, or death. People who have a higher CD4 + cell count when they begin Nevirapine treatment have a higher risk of liver problems, especially: Women with CD4 + counts higher than 250 cells/mm 3 . This group has the highest risk.

Men with CD4 + counts higher than 400 cells/mm 3 . If you are a woman with CD4 + counts higher than 250 cells/mm 3 or a man with CD4 + counts higher than 400 cells/mm 3 , you and your doctor will decide whether starting Nevirapine is right for you. In general, women have a higher risk of liver problems compared to men.

People who have abnormal liver test results before starting Nevirapine treatment and people with hepatitis B or C also have a greater chance of getting liver problems. You may get a rash if you have liver problems. Stop taking Nevirapine and call your doctor right away if you have any of the following symptoms of liver problems: dark (tea colored) urine yellowing of your skin or whites of your eyes light-colored bowel movements (stools) fever nausea (feeling sick to your stomach) feel unwell or like you have the flu pain or tenderness on your right side below your ribs tiredness loss of appetite Your doctor should see you and do blood tests often to check your liver function during the first 18 weeks of treatment with Nevirapine.

You should continue to have your liver checked regularly during your treatment with Nevirapine. It is important for you to keep all of your doctor appointments. 2.

Severe rash and skin reactions: Skin rash is the most common side effect of Nevirapine. Most rashes happen in the first 6 weeks of taking Nevirapine. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death.

Stop using Nevirapine and call your doctor right away if you get a rash with any of the following symptoms. blisters mouth sores red or inflamed eyes, like “pink eye” (conjunctivitis) liver problems (see symptoms of liver problems above) swelling of your face fever feel unwell or like you have the flu tiredness muscle or joint aches If your doctor tells you to stop treatment with Nevirapine because you have had any of the serious liver or skin problems described above, you should never take Nevirapine again. See the section “What are the possible side effects of Nevirapine?” for more information .

What is Nevirapine? Nevirapine is a prescription medicine used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Nevirapine is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI).

Nevirapine works by lowering the amount of HIV in your blood ("viral load"). You must take Nevirapine with other anti-HIV medicines . When you take Nevirapine with other anti-HIV medicines, Nevirapine can lower your viral load and increase the number of CD4 + cells ("T cells").

CD4 + cells are a type of immune helper cell in the blood. Nevirapine may not have these effects in every person. Nevirapine does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV.

People taking Nevirapine may still get infections common in people with HIV (opportunistic infections).It is very important that you stay under the care of your docto…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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