Lamivudine-Raltegravir

Lamivudine-Raltegravir is a combination medication used in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients aged 6 years and older weighing 30 kg and more.

• Lamivudine-Raltegravir is available under the following different brand names: Dutrebis

Common side effects of Lamivudine-Raltegravir include:

• headache
• nausea
• general feeling of being unwell (malaise)
• fatigue
• nasal congestion or runny nose
• diarrhea
• fever
• cough
• insomnia
• dizziness
• Serious side effects of Lamivudine-Raltegravir include:
• lactic acidosis 
• severe hepatomegaly with steatosis
• severe acute exacerbations of hepatitis B
• pancreatitis

Rare side effects of Lamivudine-Raltegravir include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

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

HIV Infection

Adult dosage

• 1 tablet (150 mg/300 mg) orally twice daily

Pediatric dosage

• Children younger than 6 years: Safety and efficacy not established
• Children aged 6 years and older and weighing 30 kg and more: 1 tablet (150 mg/300 mg) orally twice daily

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Lamivudine-Raltegravir has severe interactions with the following drugs:
  • aluminum hydroxide
  • aluminum hydroxide/magnesium carbonate
  • aluminum hydroxide/magnesium trisilicate
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • emtricitabine
  • magnesium supplement
• Lamivudine-Raltegravir has serious interactions with the following drugs:
  • betibeglogene autotemcel
  • cabotegravir
  • elivaldogene autotemcel
  • magnesium hydroxide
  • sorbitol
  • sodium sulfate/magnesium sulfate/potassium chloride
  • sodium sulfate/potassium sulfate/magnesium sulfate
  • tafenoquine
• Lamivudine-Raltegravir has moderate interactions with at least 32 other drugs
• Lamivudine-Raltegravir has minor interactions with the following drugs:
  • isavuconazonium sulfate
  • sulfamethoxazole
  • zidovudine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lamivudine-Raltegravir?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lamivudine-Raltegravir?”

Cautions

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside reverse transcriptase inhibitors (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 was reported when 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 were 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 the emergence of autoimmune disorders (e.g., 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 antiretroviral therapies (ART)
• Not recommended in combination with products containing the individual components (ie, lamivudine and raltegravir) or emtricitabine

Pregnancy and Lactation

• Use with caution if benefits outweigh risks during pregnancy
• 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