Raltegravir — Membership Pricing

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What Raltegravir is approved for (FDA label)

ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14) ] . ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated: In combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older ( 1 ). The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response ( 14 ).

Source: Read the full FDA label on DailyMed. Label effective date: July 13, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Raltegravir (FDA label)

Film-coated Tablets 400 mg pink, oval-shaped, film-coated tablets with "227" on one side. Chewable Tablets 100 mg pale orange, oval-shaped, orange-banana flavored, chewable tablets scored on both sides and imprinted on one face with the Merck logo and "477" on opposite sides of the score. 25 mg pale yellow, round, orange-banana flavored, chewable tablets with the Merck logo on one side and "473" on the other side. For Oral Suspension 100 mg white to off-white, banana flavored, granular powder that may contain yellow or beige to tan particles in a child resistant single-use foil packet. Film-Coated Tablets: 400 mg ( 3 ). Chewable Tablets: 100 mg scored and 25 mg ( 3 ).

Source: FDA prescribing information (DailyMed). Set ID: 46ef8e2e-ae63-6a3c-e054-00144ff8d46c. SPL document ID: 56861538-b6c8-1555-e063-6394a90ab5dc. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Raltegravir (FDA label)

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 ISENTRESS. 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 ).

Source: FDA prescribing information (DailyMed). Set ID: 46ef8e2e-ae63-6a3c-e054-00144ff8d46c. SPL document ID: 56861538-b6c8-1555-e063-6394a90ab5dc. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Raltegravir (FDA label)

None None ( 4 ).

Source: FDA prescribing information (DailyMed). Set ID: 46ef8e2e-ae63-6a3c-e054-00144ff8d46c. SPL document ID: 56861538-b6c8-1555-e063-6394a90ab5dc. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Raltegravir (FDA label)

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 ISENTRESS 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 ). Inform patients with phenylketonuria that the 100 mg and 25 mg chewable tablets contain phenylalanine ( 5.3 ). 5.1 Severe 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.

Source: FDA prescribing information (DailyMed). Set ID: 46ef8e2e-ae63-6a3c-e054-00144ff8d46c. SPL document ID: 56861538-b6c8-1555-e063-6394a90ab5dc. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Raltegravir (FDA label)

Coadministration of ISENTRESS 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 ISENTRESS with drugs that are strong inducers of UGT1A1, such as rifampin, may result in reduced plasma concentrations of raltegravir ( 2.1 , 7.2 ). 7.1 Effect of Raltegravir on the Pharmacokinetics of Other Agents Raltegravir does not inhibit (IC 50 >100 µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A in vitro . Moreover, in vitro , raltegravir did not induce CYP1A2, CYP2B6 or CYP3A4. A midazolam drug interaction study confirmed the low propensity of raltegravir to alter the pharmacokinetics of agents metabolized by CYP3A4 in vivo by demonstrating a lack of effect of raltegravir on the pharmacokinetics of midazolam, a sensitive CYP3A4 substrate.

Source: FDA prescribing information (DailyMed). Set ID: 46ef8e2e-ae63-6a3c-e054-00144ff8d46c. SPL document ID: 56861538-b6c8-1555-e063-6394a90ab5dc. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.