lamivudine/raltegravir (Rx)

Brand and Other Names:Dutrebis
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lamivudine/raltegravir

tablet

  • 150mg/300mg
  • Approved, but not commercially available in the United States

HIV Infection

Indicated for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients aged ≥6 years weighing at ≥30 kg

1 tablet (150 mg/300 mg) PO BID

Dosage Modifications

Renal impairment

  • CrCl <50 mL/min: Should not be used with moderate-to-severe renal impairment

Hepatic impairment

  • Mild-to-moderate: No dose adjustment required
  • Decompensated liver disease: Safety and efficacy not established
  • Severe: Not studied

Dosage Forms & Strengths

lamivudine/raltegravir

tablet

  • 150mg/300mg
  • Approved, but not commercially available in the United States

HIV Infection

Indicated for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients aged ≥6 years weighing at ≥30 kg

<6 years: Safety and efficacy not established

≥6 years and weight ≥30 kg: 1 tablet (150 mg/300 mg) PO BID

Dosage Modifications

Renal impairment

  • CrCl <50 mL/min: Should not be used with moderate-to-severe renal impairment

Hepatic impairment

  • Mild-to-moderate: No dose adjustment required
  • Decompensated liver disease: Safety and efficacy not established
  • Severe: Not studied
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Interactions

Interaction Checker

and lamivudine/raltegravir

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    Contraindicated

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            Adverse Effects

            >10% (Lamivudine)

            Cough

            Diarrhea

            Fatigue and malaise

            Fever (pediatric)

            Headache

            Musculoskeletal pain

            Nausea

            Nervous system neuropathy

            Pancreatitis

            Peripheral neuropathy

            Nasal S/S

            Vomiting

            >10% (Raltegravir)

            Total cholesterol increased (16%)

            1-10% (Lamivudine)

            Abdominal cramps, abdominal pain

            Anorexia and/or decreased appetite

            Arthralgia

            Chills

            Depression

            Dizziness

            Dyspepsia

            Insomnia

            Myalgia

            Rash

            Thrombocytopenia

            Creatine phosphokinase increased

            1-10% (Raltegravir)

            AST increased (9%)

            Glucose increased (9%)

            Hyperbilirubinemia (9%)

            Fatigue (8%)

            Nasopharyngitis (6%)

            Abdominal pain (5%)

            Cough (5%)

            Rash (5%)

            Dizziness (4%)

            Insomnia (4%)

            Vomiting (4%)

            Arthralgia (3%)

            Extremity pain (3%)

            Influenza (3%)

            Nausea

            Diarrhea

            Pyrexia

            <1% (Raltegravir)

            Asthenia GI disorders

            Lipodystrophy

            Skin disorders

            Drug related hypersensitivity

            Thrombocytopenia

            Renal failure

            Suicidal ideation

            Frequency Not Defined (Lamivudine)

            Body fat redistribution

            Elevated amylase

            Neutropenia

            Hepatitis B exacerbation

            Postmarketing Reports (Raltegravir)

            Cerebellar ataxia

            Diarrhea

            Hepatic failure

            Thrombocytopenia

            Rhabdomyolysis

            Psychiatric disorders: anxiety, depression (particularly in patients with a pre-existing history of psychiatric illness), including suicidal ideation and behaviors, paranoia

            Skin: rash, Steven’s-Johnson syndrome

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of NRTIs alone or in combination, including lamivudine and other antiretrovirals

            Post-treatment exacerbations of hepatitis in patients with HIV-1 and hepatitis B virus coinfection reported

            Pancreatitis reported; use with caution in pediatric patients with a history or prior antiretroviral nucleoside exposure, a history of pancreatitis, or other risk factors for pancreatitis; discontinue immediately if signs or symptoms of pancreatitis occur

            Hepatic decompensation reported with used with interferon- or ribavirin-based regimens; ribavirin can reduce the phosphorylation of pyrimidine NRTIs such as lamivudine

            Severe, potentially life-threatening, and fatal skin reactions reported with raltegravir, including 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 if signs or symptoms occur

            Immune reconstitution syndrome reported with combination antiretroviral therapy and may include an inflammatory response to indolent or residual opportunistic infections or emergence of autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome)

            Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” reported with ARTs

            Not recommended in combination with products containing the individual components (ie, lamivudine and raltegravir) or emtricitabine

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            Pregnancy

            Pregnancy Category: C

            Lactation: Breastfeeding is not recommended while taking lamivudine/raltegravir; additionally it is recommended that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Lamivudine: Nucleoside reverse transcriptase inhibitor (NRTI); following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog

            Raltegravir: Integrase inhibitor; inhibits catalytic activity of HIV-1 integrase, an HIV encoded enzyme required for viral replication

            Pharmacokinetics

            Bioavailability: 60% (raltegravir, fasting)

            Peak plasma time: 1 hr (raltegravir, fasting)

            Once absorbed, lamivudine and raltegravir distribution, metabolism, and excretion are similar to those of the reference components administered individually as described

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            Administration

            Instructions

            May take with or without food

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            Images

            No images available for this drug.
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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.