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Raltegravir 400 mg Tablet, Film Coated, 60-count — NDC 31722-0584-60 package photo
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Raltegravir 400 mg Tablet, Film Coated, 60-count — NDC 31722-584-60 (Billing 31722-0584-60)

by Camber Pharmaceuticals, Inc. · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Raltegravir 400 mg Tablet, Film Coated from Camber Pharmaceuticals, Inc., marketed since Dec 2024 and currently FDA-listed. It is this product's only package size.

NDC 31722-0584-60
🏷️ FDA NDC (as labeled) 31722-584-60 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 31722-584-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
31722 labeler · 584 product · 60 package
Package marketed since
Dec 19, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0331722584609
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31722-584-60
Product NDC 31722-584
11-digit billing NDC 31722058460
RxCUI 744842
UNII 43Y000U234
UPC 0331722584609
Application # ANDA203540
SPL Set ID 090aa265-9fc8-4aea-81fe-ce052c3f38df
Established class (EPC) Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of action HIV Integrase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-19
Route ORAL
Dosage form TABLET, FILM COATED
Substance RALTEGRAVIR POTASSIUM
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 744842
Why two NDCs? The FDA registers this code as 31722-584-60 — 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 → 31722-0584-60. 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 Integrase Strand Transfer Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Drug family (ATC) Integrase inhibitors
How it works HIV Integrase Inhibitors
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.

Clinical

📖 What it is MedlinePlus · NLM

Raltegravir is used to treat human immunodeficiency virus (HIV) infection. Raltegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in the blood. Although raltegravir 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 lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats HIV-1 infection and is always used with other HIV medicines. Different products are approved for different ages and weights, so your prescriber picks the right one for yo...
  • No. It can be taken with or without food. Swallow the regular tablets whole.
  • No. The forms are absorbed differently, so they are not interchangeable. Only switch if your prescriber tells you to.
  • Can I switch between the tablet, chewable tablet and suspension?
📖 Read our full Raltegravir 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.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
31722-0584-60 You're viewing this Main listing 60 TABLET, FILM COATED in 1 BOTTLE 2024-12-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Isentress 400 mg 00006-0227-61 Merck 60 tablets $34.539 AB Availability likely —
Isentress 400 mg 50090-1085-00 A-S 60 tablets — AB FDA listed —
Isentress 400 mg 68071-2113-06 NuCare 6 tablets — AB FDA listed —
Isentress 400 mg 71205-0777-14 Proficient 14 tablets — AB FDA listed —
Raltegravir 400 mgthis 31722-0584-60 Camber 60 tablets — AB 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color white
ShapeOval
ImprintHI;4
Size16 mm
ScoringNot scored
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.

🧪 Avoiding an ingredient? See Raltegravir inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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 PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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.

Manufacturer & labeler

LabelerCamber Pharmaceuticals, Inc.
Application holderHETERO LABS LTD UNIT III
FDA applicationANDA203540 (ANDA)
Labeler code31722
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio603 products on file

More NDCs from Camber Pharmaceuticals, Inc. labeler code 31722

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 116 words ▾

1 INDICATIONS AND USAGE Adult Patients: Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. Pediatric Patients: Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg. Adult Patients: Raltegravir tablets are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ( 1 ).

Pediatric Patients: Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg ( 1 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Raltegravir tablets can be administered with or without food ( 2.1 ). Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the raltegravir tablets 400 mg Adults • Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of raltegravir tablets 400 mg twice daily: • 400 mg film-coated tablet orally, twice daily ( 2.2 ). • Treatment experienced patients: • 400 mg film-coated tablet orally, twice daily ( 2.2 ). • During coadministration with rifampin in adults, 800 mg (2 x 400 mg) twice daily ( 2.2 ).

Pediatrics • If weighing at least 40 kg, and either • treatment-naïve patients or • patients who are virologically suppressed on an initial regimen of raltegravir tablets 400 mg twice daily: • 400 mg film-coated tablet orally, twice daily • If weighing at least 25 kg: One 400 mg film-coated tablet orally, twice daily.

2.1General Dosing Recommendations o Because the formulations have different pharmacokinetic profiles, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the raltegravir 400 mg film-coated tablets. o Because the extent to which raltegravir tablets may be dialyzable is unknown, dosing before a dialysis session should be avoided [see Clinical Pharmacology (12.3) ] . o Raltegravir film-coated tablets must be swallowed whole.

2.2Adults The recommended adult dosage of raltegravir film-coated tablets is displayed in Table 1. Raltegravir tablets should be taken by mouth and may be taken with or without food [see Clinical Pharmacology (12.3) ] . Table 1: Dosing Recommendations for Raltegravir Tablets in Adult Patients Population Recommended Dose Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of raltegravir tablets 400 mg twice daily 400 mg twice daily Treatment-experienced 400 mg twice daily Treatment-naïve or treatment-experienced when coadministered with rifampin [see Drug Interactions (7.1) ] 800 mg (2 x 400 mg) twice daily

2.3Pediatrics The recommended pediatric dosage of raltegravir tablets is displayed in Table 2. Raltegravir film-coated tablets should be taken by mouth and may be taken with or without food [ see C linical Pharmacology (12.3) ] . Table 2: Dosing Recommendations for Raltegravir Tablets in Pediatric Patients Recommended Pediatric Dosage and Formulation Population/Weight Film-Coated Tablets 400 mg If at least 40 kg and either: treatment-naïve or virologically suppressed on an initial regimen of raltegravir tablets 400 mg twice daily 400 mg twice daily If at least 25 kg 400 mg twice daily* If at least 4 weeks of age and weighing 3 kg to less than 25 kg NA From birth to 4 weeks (28 days) weighing at least 2 kg NA *If able to swallow a tablet

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS Raltegravir Tablets USP, 400 mg: White to off-white oval shaped film coated tablets debossed with “H I” on one side and “4” on other side of the tablet. • Film-Coated Tablets: 400 mg ( 3 ).

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 ).

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with raltegravir and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely ( 5.1 ). • Monitor for Immune Reconstitution Syndrome ( 5.2 ).

5.1Severe Skin and Hypersensitivity Reactions Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure.

Discontinue raltegravir and other suspect agents 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 aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping raltegravir treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.

5.2Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including raltegravir. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia, tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) 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.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 practice. • The most common adverse reactions of moderate to severe intensity (≥2%) are insomnia, headache, dizziness, nausea and fatigue ( 6.1 ). • Creatine kinase elevations were observed in subjects who received raltegravir. Myopathy and rhabdomyolysis have been reported.

Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions and patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Treatment-Naïve Adults The safety of raltegravir was evaluated in HIV-infected treatment-naïve subjects in 2 Phase III studies: STARTMRK evaluated raltegravir 400 mg twice daily versus efavirenz, both in combination with emtricitabine (+) tenofovir disoproxil fumarate (TDF), and ONCEMRK evaluated ISENTRESS HD 1200 mg (2 x 600 mg) once daily versus raltegravir 400 mg twice daily, both in combination with emtricitabine (+) tenofovir disoproxil fumarate. Safety data from these two studies are presented side-by-side in Tables 6 and 7 to simplify presentation; direct comparisons across trials should not be made due to differing duration of follow-up and study design.

STARTMRK (Raltegravir 400 mg twice daily) In STARTMRK, subjects received raltegravir 400 mg twice daily (N=281) or efavirenz (EFV) 600 mg at bedtime (N=282) both in combination with emtricitabine (+) tenofovir disoproxil fumarate, (N=282). During double-blind treatment, the total follow-up for subjects receiving raltegravir 400 mg twice daily + emtricitabine (+) tenofovir disoproxil fumarate was 1104 patient-years and 1036 patient-years for subjects receiving efavirenz 600 mg at bedtime + emtricitabine (+) tenofovir disoproxil fumarate.

In STARTMRK, the rate of discontinuation of therapy due to adverse events through Week 240 was 5% in subjects receiving raltegravir + emtricitabine (+) tenofovir disoproxil fumarate and 10% in subjects receiving efavirenz + emtricitabine (+) tenofovir disoproxil fumarate. ONCEMRK (ISENTRESS HD 1200 mg [2 x 600 mg] once daily) In ONCEMRK, subjects received ISENTRESS HD 1200 mg once daily (n=531) or raltegravir 400 mg twice daily (n=266) both in combination with emtricitabine (+) tenofovir disoproxil fumarate. During double-blind treatment, the total follow-up for subjects with ISENTRESS HD 1200 mg once daily was 913 patient-years and for raltegravir 400 mg twice daily was 450 patient-years.

In ONCEMRK, the rate of discontinuation of therapy due to adverse events through Week 96 was 1% in subjects receiving ISENTRESS HD 1200 mg (2 x 600 mg) once daily and 2% in subjects receiving raltegravir 400 mg twice daily. Clinical adverse reactions of moderate to severe intensity occurring in ≥2% of treatment-naïve subjects treated with raltegravir 400 mg twice daily or efavirenz in STARTMRK through Week 240 or ISENTRESS HD 1200 mg once daily or raltegravir 400 mg twice daily in ONCEMRK through Week 96 are presented in Table 6.

In STARTMRK, clinical adverse reactions of all intensities (mild, moderate and severe) occurring in ≥2% of subjects on raltegravir 400 mg twice daily through Week 240 also include diarrhea, flatulence, asthenia, decreased appetite, abnormal dreams, depression and nightmare. In ONCEMRK, clinical adverse reactions of all intensities (mild, moderate and severe) occurring in ≥2% of subjects on ISENTRESS HD or raltegravir 400 mg twice daily through Week 96 also include abdominal pain, diarrhea, vomiting, and decreased appetite.

Table 6: Adverse Reactions* of Moderate to Se… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Coadministration of raltegravir and other drugs may alter the plasma concentration of raltegravir. The potential for drug-drug interactions must be considered prior to and during therapy ( 7 ). • Coadministration of raltegravir with drugs that are strong inducers of UGT1A1, such as rifampin, may result in reduced plasma concentrations of raltegravir ( 2.1 , 7.1 ).

7.1Effect of Other Agents on the Pharmacokinetics of Raltegravir Raltegravir is not a substrate of cytochrome P450 (CYP) enzymes. Based on in vivo and in vitro studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway. Coadministration of raltegravir with drugs that inhibit UGT1A1 may increase plasma levels of raltegravir and coadministration of raltegravir with drugs that induce UGT1A1, such as rifampin, may reduce plasma levels of raltegravir (see Table 11).

Selected drug interactions are presented in Table 11 [see Clinical Pharmacology (12.3) ] . In some cases, recommendations differ for raltegravir. Table 11: Selected Drug Interactions in Adults Concomitant Drug Class: Drug Name Effect on Concentration of Raltegravir Clinical Comment for Raltegravir Metal-Containing Antacids Aluminum and/or magnesium-containing antacids ↓ Coadministration or staggered administration is not recommended.

Calcium carbonate antacid ↓ No dose adjustment Other Agents Rifampin ↓ The recommended dosage is 800 mg twice daily during coadministration with rifampin. There are no data to guide co-administration of raltegravir with rifampin in patients below 18 years of age [see Dosage and Administration (2.1) ]. Tipranavir/ritonavir No dose adjustment Etravirine ↓ No dose adjustment Strong inducers of drug metabolizing enzymes not mentioned above e.g., Carbamazepine Phenobarbital Phenytoin ↓↔ The impact of other strong inducers of drug metabolizing enzymes on raltegravir is unknown.

Coadministration is not recommended.

7.2Drugs without Clinically Significant Interactions with Raltegravir In drug interaction studies performed using raltegravir film-coated tablets 400 mg twice daily dose, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of the following: ethinyl estradiol/norgestimate, methadone, midazolam, lamivudine, tenofovir disoproxil fumarate, etravirine, darunavir/ritonavir, or boceprevir. Moreover, atazanavir, atazanavir/ritonavir, boceprevir, calcium carbonate antacids, darunavir/ritonavir, efavirenz, etravirine, omeprazole, or tipranavir/ritonavir did not have a clinically meaningful effect on the pharmacokinetics of 400 mg twice daily raltegravir.

No dose adjustment is required when raltegravir 400 mg twice daily is coadministered with these drugs. There is no predicted pharmacokinetic drug interaction between raltegravir and tenofovir alafenamide.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission ( 8.2 ).

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data).

The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15-20%. The background risk for major birth defects and miscarriage for the indicated population is unknown.

Methodological limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation (see Data) . In animal reproduction studies in rats and rabbits, no evidence of adverse developmental outcomes was observed with oral administration of raltegravir during organogenesis at doses that produced exposures up to approximately 4 times the maximum recommended human dose (MRHD) of 1200 mg (see Data) .

Data Human Data Based on prospective reports from the APR of over 850 exposures to raltegravir during pregnancy resulting in live births (including over 450 exposures in the first trimester), there was no difference between the overall risk of birth defects for raltegravir compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP. The prevalence of defects in live births was 3.1% (95% CI: 1.7% to 5.1%) following first trimester exposure to raltegravir-containing regimens and 3.7% (95% CI: 2.1% to 6.0%) following second and third trimester exposure to raltegravir-containing regimens.

There are limited data on the use of raltegravir 1200 mg (2 x 600 mg) once daily in pregnant women. Animal Data In a combined embryo/fetal and pre/postnatal development study, raltegravir was administered orally to rats at doses of 100, 300, 600 mg/kg/day on gestation day 6 to 20 or from gestation day 6 to lactation day 20. No effects on pre/postnatal development were observed up to the highest dose tested.

Embryo-fetal findings were limited to an increase in the incidence of supernumerary ribs in the 600 mg/kg/day group. Systemic exposure (AUC) at 600 mg/kg/day was approximately 3 times higher than exposure at the MRHD of 1200 mg. In pregnant rabbits, raltegravir was administered orally at doses of 100, 500, or 1000 mg/kg/day during the gestation days 7 to 20.

No embryo/fetal effects were noted up to the highest dose of 1000 mg/kg/day. Systemic exposure (AUC) at 1000 mg/kg/day was approximately 4 times higher than exposures at the MRHD of 1200 mg. In both species, raltegravir has been shown to cross the placenta, with fetal plasma concentrations observed in rats approximately 1.5 to 2.5 times greater than in maternal plasma and fetal plasma concentrations in rabbits approximately 2% that of maternal concentrations on gestation day 20.

8.2Lactation Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. There are no data on the presence of raltegravir in human milk, the effects on the breastfed infant, or the effects on milk production. When administered to lactating rats, raltegravir was present in milk [see Data].

Because of the potential for: 1) HIV transmission (in HIV-negative infants), 2) developing viral resistance… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data).

The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15-20%. The background risk for major birth defects and miscarriage for the indicated population is unknown.

Methodological limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation (see Data) . In animal reproduction studies in rats and rabbits, no evidence of adverse developmental outcomes was observed with oral administration of raltegravir during organogenesis at doses that produced exposures up to approximately 4 times the maximum recommended human dose (MRHD) of 1200 mg (see Data) .

Data Human Data Based on prospective reports from the APR of over 850 exposures to raltegravir during pregnancy resulting in live births (including over 450 exposures in the first trimester), there was no difference between the overall risk of birth defects for raltegravir compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP. The prevalence of defects in live births was 3.1% (95% CI: 1.7% to 5.1%) following first trimester exposure to raltegravir-containing regimens and 3.7% (95% CI: 2.1% to 6.0%) following second and third trimester exposure to raltegravir-containing regimens.

There are limited data on the use of raltegravir 1200 mg (2 x 600 mg) once daily in pregnant women. Animal Data In a combined embryo/fetal and pre/postnatal development study, raltegravir was administered orally to rats at doses of 100, 300, 600 mg/kg/day on gestation day 6 to 20 or from gestation day 6 to lactation day 20. No effects on pre/postnatal development were observed up to the highest dose tested.

Embryo-fetal findings were limited to an increase in the incidence of supernumerary ribs in the 600 mg/kg/day group. Systemic exposure (AUC) at 600 mg/kg/day was approximately 3 times higher than exposure at the MRHD of 1200 mg. In pregnant rabbits, raltegravir was administered orally at doses of 100, 500, or 1000 mg/kg/day during the gestation days 7 to 20.

No embryo/fetal effects were noted up to the highest dose of 1000 mg/kg/day. Systemic exposure (AUC) at 1000 mg/kg/day was approximately 4 times higher than exposures at the MRHD of 1200 mg. In both species, raltegravir has been shown to cross the placenta, with fetal plasma concentrations observed in rats approximately 1.5 to 2.5 times greater than in maternal plasma and fetal plasma concentrations in rabbits approximately 2% that of maternal concentrations on gestation day 20.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use HIV-1 Infected Children The safety, tolerability, pharmacokinetic profile, and efficacy of twice daily raltegravir were evaluated in HIV-1 infected infants, children and adolescents 4 weeks to 18 years of age in an open-label, multicenter clinical trial, IMPAACT P1066 [see Dosage and Administration (2.3) , Clinical Pharmacology (12.3) and Clinical Studies (14.4)]. The safety profile was comparable to that observed in adults [see Adverse Reactions (6.1) ] . HIV-1 Exposed Neonates The safety and pharmacokinetics of ISENTRESS for oral suspension were evaluated in 42 full-term HIV-1 exposed neonates at high risk of acquiring HIV-1 infection in a Phase 1, open-label, multicenter clinical study, IMPAACT P1110.

Cohort 1 neonates received 2 single doses of ISENTRESS for oral suspension: the first within 48 hours of birth and the second at 7 to 10 days of age. Cohort 2 neonates received daily dosing of ISENTRESS for oral suspension for 6 weeks: 1.5 mg/kg once daily starting within 48 hours of birth through Day 7 (week 1); 3 mg/kg twice daily on Days 8 to 28 of age (weeks 2 to 4); and 6 mg/kg twice daily on Days 29 to 42 of age (weeks 5 and 6). Sixteen neonates were enrolled in Cohort 1 (10 were exposed and 6 were unexposed to raltegravir in utero) and 26 in Cohort 2 (all unexposed to raltegravir in utero); all infants received a standard of care antiretroviral drug regimen for prevention of mother to child transmission.

All enrolled neonates were followed for safety for a duration of 24 weeks. The 42 infants were 52% male, 69% Black and 12% Caucasian. HIV-1 status was assessed by nucleic acid test at birth, week 6 and week 24; all patients were HIV-1 negative at completion of the study.

The safety profile was comparable to that observed in adults [see Adverse Reactions (6.1) ] . Raltegravir is not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg.

🧓 Geriatric Use 73 words ▾

8.5Geriatric Use Clinical studies of raltegravir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and 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 48 words ▾

10 OVERDOSAGE In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required. The extent to which raltegravir may be dialyzable is unknown.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Raltegravir is an HIV-1 antiviral drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics In a monotherapy study raltegravir (400 mg twice daily) demonstrated rapid antiviral activity with mean viral load reduction of 1.66 log 10 copies/mL by Day 10. Cardiac Electrophysiology At a dose 1.33 times the maximum approved recommended dose (and peak concentrations 1.25-fold higher than the maximum approved dose), raltegravir does not prolong the QT interval or PR interval to any clinically relevant extent.

12.3Pharmacokinetics Adults Absorption Raltegravir, given 400 mg twice daily, is absorbed with a T max of approximately 3 hours postdose in the fasted state in healthy subjects. Raltegravir 1200 mg once daily is rapidly absorbed with median T max of ~1.5 to 2 hours in the fasted state. Raltegravir increases dose proportionally (AUC and C max ) or slightly less than dose proportionally (C 12hr ) over the dose range 100 mg to 1600 mg.

The absolute bioavailability of raltegravir has not been established. The chewable tablet and oral suspension have higher oral bioavailability compared to the 400 mg film-coated tablet. Relative to the raltegravir 400 mg formulation, the raltegravir 600 mg formulation has higher relative bioavailability.

Steady-state is generally reached in 2 days, with little to no accumulation with multiple dose administration for the 400 mg twice daily and 1200 once daily formulation. Effect of Food on Oral Absorption The food effect of various formulations are presented in Table 12. Table 12: Effect of Food on the Pharmacokinetics of Raltegravir Formulations PK parameter ratio (fed/fasted) Formulation Meal Type AUC Ratio (90% CI) C max Ratio (90% CI) C min Ratio (90% CI) 400 mg twice daily Low Fat 0.54 (0.41 to 0.71) 0.48 (0.35 to 0.67) 0.86 (0.54 to 1.36) Moderate Fat 1.13 (0.85 to 1.49) 1.05 (0.75 to 1.46) 1.66 (1.04 to 2.64) High Fat 2.11 (1.60 to 2.80) 1.96 (1.41 to 2.73) 4.13 (2.60 to 6.57) 1200 mg once daily Low Fat 0.58 (0.46 to 0.74) 0.48 (0.37 to 0.62) 0.84 (0.63 to 1.10) High Fat 1.02 (0.86 to 1.21) 0.72 (0.58 to 0.90) 0.88 (0.66 to 1.18) Chewable tablet High Fat 0.94 (0.78 to 1.14) 0.38 (0.28 to 0.52) 2.88 (2.21 to 3.75) Oral suspension The effect of food on oral suspension was not studied.

Low-fat meal: 300 Kcal, 2.5 g fat Moderate-fat meal: 600 Kcal, 21 g fat High-fat meal: 825 Kcal, 52 g fat Distribution Raltegravir is approximately 83% bound to human plasma protein over the concentration range of 2 to 10 µM. In one study of HIV-1 infected subjects who received raltegravir 400 mg twice daily, raltegravir was measured in the cerebrospinal fluid. In the study (n=18), the median cerebrospinal fluid concentration was 5.8% (range 1 to 53.5%) of the corresponding plasma concentration.

This median proportion was approximately 3-fold lower than the free fraction of raltegravir in plasma. The clinical relevance of this finding is unknown. Metabolism and Excretion The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter α-phase half-life (~1 hour) accounting for much of the AUC.

Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32% of the dose was excreted in feces and urine, respectively. In feces, only raltegravir was present, most of which is likely derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species. Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23% of the dose, respectively.

The major circulating entity was raltegravir and represented approximately 70% of the total radioactivity; the remaining radioactivity in plasma was accounted for by raltegravir-glucuronide. The major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation. Table 13: Multiple-Dose Pharmacokinetic Parameters of Raltegravir Following the Administration of 400 mg… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Raltegravir is an HIV-1 antiviral drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 72 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Raltegravir tablets USP, 400 mg are white to off-white oval shaped film coated tablets debossed with “H I” on one side and “4” on other side of the tablet. They are supplied as follows: Bottles of 60 tablets (NDC 31722-584-60) Storage and Handling Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .

📋 Description 142 words ▾

11 DESCRIPTION Raltegravir tablets, USP contain raltegravir potassium USP, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorobenzyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The molecular formula is C 20 H 20 FKN 6 O 5 and the molecular weight is 482.51.

The structural formula is: Raltegravir potassium, USP is white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in acetonitrile and ethanol, insoluble in isopropyl alcohol. Each 400 mg film-coated tablet of raltegravir for oral administration contains 434.4 mg of raltegravir potassium USP, equivalent to 400 mg of raltegravir and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene oxide, sodium stearyl fumarate.

The tablets are coated with opadry II white containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. raltegravirtab400mgstructure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Patient Information). Severe and Potentially Life-threatening Rash Inform patients that severe and potentially life-threatening rash has been reported. Advise patients to immediately contact their healthcare provider if they develop rash.

Instruct patients to immediately stop taking raltegravir and other suspect agents, and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of a more serious reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis or severe hypersensitivity: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes, lips, mouth, breathing difficulty, and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on the right side below the ribs).

Inform patients that if severe rash occurs, their physician will closely monitor them, order laboratory tests and initiate appropriate therapy. Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.2)] . Rhabdomyolysis Before patients begin raltegravir, ask them if they have a history of rhabdomyolysis, myopathy or increased creatine kinase or if they are taking medications known to cause these conditions such as statins, fenofibrate, gemfibrozil or zidovudine [see Adverse Reactions (6.1)] .

Instruct patients to immediately report to their healthcare provider any unexplained muscle pain, tenderness, or weakness while taking raltegravir. Drug Interactions Inform patients that raltegravir may interact with some drugs and ask them to identify all their current medications including over-the-counter agents [see Drug Interactions (7.2)] . Missed Dosage Inform patients that it is important to take raltegravir on a regular dosing schedule as instructed by their healthcare provider and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2)] .

Important Administration Instructions Film-Coated Tablets Inform patients that the film-coated tablets must be swallowed whole. Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to raltegravir during pregnancy [see Use in Specific Populations (8.1)] . Lactation Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)] .

Brands listed are the trademarks of their respective owners. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 by: HETERO TM Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, India. Revised: 05/2026 raltegravirtab400mgcamlogo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Adults Absorption Raltegravir, given 400 mg twice daily, is absorbed with a T max of approximately 3 hours postdose in the fasted state in healthy subjects. Raltegravir 1200 mg once daily is rapidly absorbed with median T max of ~1.5 to 2 hours in the fasted state. Raltegravir increases dose proportionally (AUC and C max ) or slightly less than dose proportionally (C 12hr ) over the dose range 100 mg to 1600 mg.

The absolute bioavailability of raltegravir has not been established. The chewable tablet and oral suspension have higher oral bioavailability compared to the 400 mg film-coated tablet. Relative to the raltegravir 400 mg formulation, the raltegravir 600 mg formulation has higher relative bioavailability.

Steady-state is generally reached in 2 days, with little to no accumulation with multiple dose administration for the 400 mg twice daily and 1200 once daily formulation. Effect of Food on Oral Absorption The food effect of various formulations are presented in Table 12. Table 12: Effect of Food on the Pharmacokinetics of Raltegravir Formulations PK parameter ratio (fed/fasted) Formulation Meal Type AUC Ratio (90% CI) C max Ratio (90% CI) C min Ratio (90% CI) 400 mg twice daily Low Fat 0.54 (0.41 to 0.71) 0.48 (0.35 to 0.67) 0.86 (0.54 to 1.36) Moderate Fat 1.13 (0.85 to 1.49) 1.05 (0.75 to 1.46) 1.66 (1.04 to 2.64) High Fat 2.11 (1.60 to 2.80) 1.96 (1.41 to 2.73) 4.13 (2.60 to 6.57) 1200 mg once daily Low Fat 0.58 (0.46 to 0.74) 0.48 (0.37 to 0.62) 0.84 (0.63 to 1.10) High Fat 1.02 (0.86 to 1.21) 0.72 (0.58 to 0.90) 0.88 (0.66 to 1.18) Chewable tablet High Fat 0.94 (0.78 to 1.14) 0.38 (0.28 to 0.52) 2.88 (2.21 to 3.75) Oral suspension The effect of food on oral suspension was not studied.

Low-fat meal: 300 Kcal, 2.5 g fat Moderate-fat meal: 600 Kcal, 21 g fat High-fat meal: 825 Kcal, 52 g fat Distribution Raltegravir is approximately 83% bound to human plasma protein over the concentration range of 2 to 10 µM. In one study of HIV-1 infected subjects who received raltegravir 400 mg twice daily, raltegravir was measured in the cerebrospinal fluid. In the study (n=18), the median cerebrospinal fluid concentration was 5.8% (range 1 to 53.5%) of the corresponding plasma concentration.

This median proportion was approximately 3-fold lower than the free fraction of raltegravir in plasma. The clinical relevance of this finding is unknown. Metabolism and Excretion The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter α-phase half-life (~1 hour) accounting for much of the AUC.

Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32% of the dose was excreted in feces and urine, respectively. In feces, only raltegravir was present, most of which is likely derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species. Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23% of the dose, respectively.

The major circulating entity was raltegravir and represented approximately 70% of the total radioactivity; the remaining radioactivity in plasma was accounted for by raltegravir-glucuronide. The major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation. Table 13: Multiple-Dose Pharmacokinetic Parameters of Raltegravir Following the Administration of 400 mg Twice Daily and 1200 mg Once Daily in HIV-infected Subjects Parameter 400 mg BID Geometric Mean (%CV) N=6 1200 mg QD Geometric Mean (%CV) N=524 AUC (µM ∙ hr) AUC 0-12 = 14.3 (88.6) AUC 0-24 = 55.3 (41.5) C max (µM) 4.5 (128) 15.7 (45.8) C min (nM) C 12 = 142 (63.8) C 24 = 107 (97.5) Special Populations Pediatric Raltegravir Two pediatric formulations were evaluated in healthy adult volunteers, where the chewable tablet and oral suspension were compared to the 400 mg tablet.

The chewable tablet and oral suspension demonstrated higher oral bioavailabil… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 65 words ▾

12.2Pharmacodynamics In a monotherapy study raltegravir (400 mg twice daily) demonstrated rapid antiviral activity with mean viral load reduction of 1.66 log 10 copies/mL by Day 10. Cardiac Electrophysiology At a dose 1.33 times the maximum approved recommended dose (and peak concentrations 1.25-fold higher than the maximum approved dose), raltegravir does not prolong the QT interval or PR interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Description of Clinical Studies The evidence of durable efficacy of raltegravir 400 mg twice daily is based on the analyses of 240-week data from a randomized, double-blind, active-controlled trial, STARTMRK evaluating raltegravir 400 mg twice daily in antiretroviral treatment-naïve HIV-1 infected adult subjects, the analysis of 96-week data from a randomized, double-blind, active-control trial, ONCEMRK evaluating ISENTRESS HD 1200 mg (2 × 600 mg) once daily in treatment-naïve adult subjects, and 96-week data from 2 randomized, double-blind, placebo-controlled studies, BENCHMRK 1 and BENCHMRK 2, evaluating raltegravir 400 mg twice daily in antiretroviral treatment-experienced HIV-1 infected adult subjects.

See Table 18. Table 18: Trials Conducted with Raltegravir in Subjects with HIV-1 Infection Trial Study Type Population Study Arms (N) Dose/Formulation Time point STARTMRK Randomized, double-blind, active-controlled Treatment-Naïve Adults Raltegravir 400 mg Twice Daily (281) Efavirenz 600 mg At Bedtime (282) Both in combination with emtricitabine (+) tenofovir disoproxil fumarate 400 mg film-coated tablet Week 240 ONCEMRK Randomized, double-blind, active-controlled Treatment-Naïve Adults ISENTRESS HD 1200 mg Once Daily (531) Raltegravir 400 mg Twice Daily (266) Both in combination with emtricitabine (+) tenofovir disoproxil fumarate 600 mg film-coated tablet Week 96 400 mg film-coated tablet BENCHMRK 1 Randomized, double-blind, placebo-controlled Treatment-Experienced Adults Raltegravir 400 mg Twice Daily (232) Placebo (118) Both in combination with optimized background therapy 400 mg film-coated tablet Week 240 (Week 156 on double-blind plus Week 84 on open-label) BENCHMRK 2 Randomized, double-blind, placebo-controlled Treatment-Experienced Adults Raltegravir 400 mg Twice Daily (230) Placebo (119) Both in combination with optimized background therapy 400 mg film-coated tablet Week 240 (Week 156 on double-blind plus Week 84 on open-label) IMPAACT P1066 Open-label, non-comparative Pediatric Patients – 4 weeks to 18 years of age (Treatment-Experienced or Failed Prior PMTCT) Raltegravir 400 mg tablet Twice Daily – 12 to 18 years or 6 to <12 years and ≥25 kg (87) ISENTRESS chewable tablet- Weight-Based Dose to Approximate 6 mg/kg Twice Daily – 2 to <12 years (39) ISENTRESS for oral suspension- Weight-Based Dose to Approximate 6 mg/kg Twice Daily – 4 weeks to <2 years (26) In combination with optimized background therapy 400 mg film-coated tablet 25 mg and 100 mg chewable tablet 100 mg sachet for oral suspension Week 240

14.2Treatment-Naïve Adult Subjects STARTMRK (Raltegravir 400 mg twice daily) STARTMRK is a Phase 3 randomized, international, double-blind, active-controlled trial to evaluate the safety and efficacy of raltegravir 400 mg twice daily versus efavirenz 600 mg at bedtime both with emtricitabine (+) tenofovir disoproxil fumarate in treatment-naïve HIV-1-infected subjects with HIV-1 RNA >5000 copies/mL. Randomization was stratified by screening HIV-1 RNA level (≤50,000 copies/mL; or >50,000 copies/mL) and by hepatitis status.

In STARTMRK, 563 subjects were randomized and received at least 1 dose of either raltegravir 400 mg twice daily or efavirenz 600 mg at bedtime, both in combination with emtricitabine (+) tenofovir disoproxil fumarate. There were 563 subjects included in the efficacy and safety analyses. At baseline, the median age of subjects was 37 years (range 19 to 71), 19% female, 58% non-white, 6% had hepatitis B and/or C virus co-infection, 20% were CDC Class C (AIDS), 53% had HIV-1 RNA greater than 100,000 copies per mL, and 47% had CD4+ cell count less than 200 cells per mm3; the frequencies of these baseline characteristics were similar between treatment groups.

ONCEMRK (ISENTRESS HD 1200 mg [2 x 600 mg] once daily) ONCEMRK is a Phase 3 randomized, international, double-blind, active-controlled trial to evaluate the safety and efficacy of ISENTRESS HD 1200 mg (2 x 600 mg) once da… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 209 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies of raltegravir in mice did not show any carcinogenic potential. At the highest dose levels, 400 mg/kg/day in females and 250 mg/kg/day in males, systemic exposure was 1.8-fold (females) or 1.2-fold (males) greater than the AUC (54 μM●hr) at the 400-mg twice daily human dose. Treatment-related squamous cell carcinoma of nose/nasopharynx was observed in female rats dosed with 600 mg/kg/day raltegravir for 104 weeks.

These tumors were possibly the result of local irritation and inflammation due to local deposition and/or aspiration of drug in the mucosa of the nose/nasopharynx during dosing. No tumors of the nose/nasopharynx were observed in rats dosed with 150 mg/kg/day (males) and 50 mg/kg/day (females) and the systemic exposure in rats was 1.7-fold (males) to 1.4-fold (females) greater than the AUC (54 μM●hr) at the 400 mg twice daily human dose. No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage, and in vitro and in vivo chromosomal aberration studies.

No effect on fertility was seen in male and female rats at doses up to 600 mg/kg/day which resulted in a 3-fold exposure above the exposure at the recommended human dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 206 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies of raltegravir in mice did not show any carcinogenic potential. At the highest dose levels, 400 mg/kg/day in females and 250 mg/kg/day in males, systemic exposure was 1.8-fold (females) or 1.2-fold (males) greater than the AUC (54 μM●hr) at the 400-mg twice daily human dose. Treatment-related squamous cell carcinoma of nose/nasopharynx was observed in female rats dosed with 600 mg/kg/day raltegravir for 104 weeks.

These tumors were possibly the result of local irritation and inflammation due to local deposition and/or aspiration of drug in the mucosa of the nose/nasopharynx during dosing. No tumors of the nose/nasopharynx were observed in rats dosed with 150 mg/kg/day (males) and 50 mg/kg/day (females) and the systemic exposure in rats was 1.7-fold (males) to 1.4-fold (females) greater than the AUC (54 μM●hr) at the 400 mg twice daily human dose. No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage, and in vitro and in vivo chromosomal aberration studies.

No effect on fertility was seen in male and female rats at doses up to 600 mg/kg/day which resulted in a 3-fold exposure above the exposure at the recommended human dose.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Raltegravir Tablets, USP What are raltegravir tablets? Raltegravir tablets are a prescription medicine used with other HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults, and in children weighing at least 4.4 pounds (2 kg). HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Raltegravir tablets should not be used in children who weigh less than 4.4 pounds (2 kg). Before you take raltegravir tablets, tell your doctor about all of your medical conditions, including if you: • have liver problems • have a history of a muscle disorder called rhabdomyolysis or myopathy • have increased levels of creatine kinase in your blood • receive kidney dialysis treatment • are pregnant or plan to become pregnant. It is not known if raltegravir tablets can harm your unborn baby.

Pregnancy Registry: There is a pregnancy registry for women who take raltegravir tablets during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry. • are breastfeeding or plan to breastfeed.

Do not breastfeed if you take raltegravir tablets. o You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. o It is not known if raltegravir can pass into your breast milk. o Talk with your doctor about the best way to feed your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with raltegravir tablets. • Keep a list of your medicines to show your doctor and pharmacist. • You can ask your doctor or pharmacist for a list of medicines that interact with raltegravir tablets. • Do not start taking a new medicine without telling your doctor.

Your doctor can tell you if it is safe to take raltegravir tablets with other medicines. How should I take raltegravir tablets? • Take raltegravir tablets exactly as prescribed by your doctor. • Do not change your dose of raltegravir tablets or stop your treatment without talking with your doctor first. • Stay under the care of your doctor during treatment with raltegravir tablets. • Raltegravir film-coated tablets must be swallowed whole . • Do not switch between the film-coated tablet, the chewable tablet, or the oral suspension without talking with your doctor first. • Do not switch between the raltegravir 400 mg film-coated tablet and the ISENTRESS HD 600 mg film-coated tablet if your prescribed dose is 1200 mg. • Do not run out of raltegravir tablets.

The virus in your blood may increase and the virus may become harder to treat. Get a refill of your raltegravir tablets from your doctor or pharmacy before you run out. • Take raltegravir tablets on a regular dosing schedule as instructed by your doctor. Do not miss doses. • If you take too much raltegravir, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of raltegravir tablets? Raltegravir tablets can cause serious side effects including: • Severe skin reactions and allergic reactions. Some people who take raltegravir tablets develop severe skin reactions and allergic reactions that can be serious, and may be life-threatening or lead to death. o If you develop a rash, call your doctor right away. o If you develop a rash with any of the following symptoms, stop using raltegravir tablets and call your doctor or get medical help right away: • fever • blisters or peeling of the skin • generally ill feeling • redness or swelling of the eyes • extreme tiredness • swelling of the mouth, lips, or face • muscle or joint aches • problems breathing • blisters or sores in mouth Sometimes allergic reactions can affect body organs, such as your liver.

Call your doctor right away if you have any of the following signs or symptoms of liver problems: • yellowing of your skin or whites of your eyes • nausea o… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 14 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Raltegravir Tablets, 400 mg - 60s Count Container Label raltegravirtab400mglabel

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Raltegravir — the ingredient across all brands.

Top reported reactions

Drug Interaction1,211
Foetal Exposure During Pregnancy1,078
Depression1,017
Anxiety966
Pain917
Emotional Distress789
Anhedonia708

Age at onset

Neonate184
Infant60
Child18
Adolescent17
Adult2,611
Elderly267

Reporter sex

16,416 reports
Male · 65%
Female · 34%
Unknown · 1%

Serious outcomes

Hospitalization5,030
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,491 94
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Camber Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Camber Pharmaceuticals, Inc. 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.
← 31722-0580-60 · Camber 31722-0585-01 · Camber →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.