Generic Name: Raltegravir Brand Name(s): Generics only. No brands available.

Uses

What is Raltegravir used for?

Raltegravir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Raltegravir is known as an integrase inhibitor. It blocks the virus from growing and infecting more cells.

Raltegravir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How should I take Raltegravir?

You may take raltegravir with or without food.

The raltegravir chewable tablet may be chewed or swallowed whole.

Do not crush, chew, or break a regular tablet. Swallow it whole.

Raltegravir oral suspension is a powder that must be mixed with water before you take it. Mix 1 packet of this powder with 1 teaspoon (5 milliliters) of water. Measure this mixture with the dosing syringe provided, and give the medicine by mouth within 30 minutes after mixing. Do not save any of the mixed medicine for later use.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Raltegravir doses are based on weight in children, and any changes may affect your child’s dose.

If your doctor changes your brand, strength, or type of raltegravir, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of raltegravir you receive at the pharmacy.

Use raltegravir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice. Every person with HIV or AIDS should remain under the care of a doctor.

How do I store Raltegravir?

Raltegravir is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Raltegravir in the bathroom or the freezer. There may be different brands of Raltegravir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Raltegravir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Raltegravir?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B, hepatitis C), muscle disorders (such as rhabdomyolysis, myopathy), high blood levels of creatine kinase (high CK test results).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and raltegravir may be part of that treatment. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Raltegravir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Raltegravir. Raltegravir is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Raltegravir?

Headache, nausea, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), persistent nausea/vomiting, loss of appetite, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash (especially if you also have fever, blisters, mouth sores, eye redness/swelling, muscle/joint pain), itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Raltegravir?

A product that may interact with this drug is: orlistat.

Raltegravir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Raltegravir?

Raltegravir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Raltegravir?

Raltegravir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Raltegravir.

What is the dose of Raltegravir for an adult?

Usual Adult Dose for HIV Infection

Therapy-naive patients or patients virologically-suppressed on an initial regimen of film-coated tablets 400 mg twice a day:

-Film-Coated Tablets 600 mg: 1200 mg orally once a day

-Film-Coated Tablets 400 mg: 400 mg orally twice a day

Therapy-experienced patients:

-Film-Coated Tablets 400 mg: 400 mg orally twice a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Occupational Exposure

US Public Health Service Working Group Recommendations:

-Film-Coated Tablets 400 mg: 400 mg orally twice a day

Duration of therapy: 28 days, if tolerated

Comments:

-This drug plus emtricitabine-tenofovir disoproxil fumarate is recommended as the preferred regimen for HIV postexposure prophylaxis; this drug is also recommended as a component in various alternative regimens.

-Prophylaxis should be started as soon as possible, preferably within hours after exposure.

-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.

-Current guidelines should be consulted for additional information.

Usual Adult Dose for Nonoccupational Exposure

US CDC Recommendations:

-Film-Coated Tablets 400 mg: 400 mg orally twice a day

Duration of therapy: 28 days

Comments:

-This drug is recommended as a component of a preferred 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection; if other alternatives are considered, this drug is recommended as a component in various regimens.

-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Film-Coated Tablets 400 mg, Chewable Tablets, Oral Suspension:

-Mild to moderate liver dysfunction: No adjustment recommended.

-Severe liver dysfunction: Data not available

Film-Coated Tablets 600 mg:

-Liver dysfunction: Not recommended.

Dose Adjustments

Concomitant rifampin:

Adults (therapy-naive or therapy-experienced):

-Film-Coated Tablets 400 mg: 800 mg orally twice a day

Dialysis

-Dosing before a dialysis session should be avoided; extent that drug may be dialyzable unknown.

Other Comments

Administration advice:

-May administer without regard to food

-Film-coated tablets: Swallow whole.

-Chewable tablets: May chew or swallow whole

-Oral suspension: Do not shake; administer within 30 minutes of mixing.

-Due to different pharmacokinetic profiles, do not substitute the chewable tablets or oral suspension for either film-coated tablet and do not substitute the film-coated tablet 400 mg for the film-coated tablet 600 mg to create a 1200 mg once daily dose.

-If a pediatric patient weighing at least 25 kg is unable to swallow a film-coated tablet 400 mg, use the chewable tablet regimen.

-Do not use with antacids that contain aluminum and/or magnesium; do not coadminister film-coated tablets 600 mg with calcium carbonate antacids.

-Consult the manufacturer product information regarding missed doses.

Storage requirements:

-Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

-Film-coated and chewable tablets: Store in original package with bottle closed tightly; keep desiccant in bottle to protect from moisture.

-Oral suspension: Store in original container; do not open foil packet until ready for use.

Reconstitution/preparation techniques:

-Oral suspension: The manufacturer product information should be consulted.

General:

-The 25 and 100 mg chewable tablets contain about 0.05 and 0.1 mg phenylalanine, respectively, which can be harmful to patients with phenylketonuria.

-Each single-use packet for oral suspension contains 100 mg of raltegravir; when suspended, the final concentration is 10 mg/mL.

Patient advice:

-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).

-If rash develops, contact healthcare provider at once; if rash develops with fever, general ill feeling, extreme tiredness, muscle/joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes/lips/mouth, difficulty breathing, and/or signs/symptoms of liver problems, stop therapy immediately and seek medical care.

-Notify healthcare provider at once of any symptoms of infection.

-If unexplained muscle pain, tenderness, or weakness occurs, contact healthcare provider at once.

What is the dose of Raltegravir for a child?

Usual Pediatric Dose for HIV Infection

ORAL SUSPENSION:

Full-term neonates (birth to 4 weeks [28 days] of age):

Birth to 1 week:

-Weight 2 to less than 3 kg: 4 mg orally once a day

-Weight 3 to less than 4 kg: 5 mg orally once a day

-Weight 4 to less than 5 kg: 7 mg orally once a day

1 to 4 weeks:

-Weight 2 to less than 3 kg: 8 mg orally twice a day

-Weight 3 to less than 4 kg: 10 mg orally twice a day

-Weight 4 to less than 5 kg: 15 mg orally twice a day

Pediatric patients at least 4 weeks of age:

-Weight 3 to less than 4 kg: 25 mg orally twice a day

-Weight 4 to less than 6 kg: 30 mg orally twice a day

-Weight 6 to less than 8 kg: 40 mg orally twice a day

-Weight 8 to less than 11 kg: 60 mg orally twice a day

-Weight 11 to less than 14 kg: 80 mg orally twice a day

-Weight 14 to less than 20 kg: 100 mg orally twice a day

CHEWABLE TABLETS:

-Weight 11 to less than 14 kg: 75 mg orally twice a day

-Weight 14 to less than 20 kg: 100 mg orally twice a day

-Weight 20 to less than 28 kg: 150 mg orally twice a day

-Weight 28 to less than 40 kg: 200 mg orally twice a day

-Weight at least 40 kg: 300 mg orally twice a day

FILM-COATED TABLETS 400 MG:

-Weight at least 25 kg: 400 mg orally twice a day

FILM-COATED TABLETS 600 MG:

-Weight at least 40 kg and either therapy-naive or virologically-suppressed on an initial regimen of film-coated tablets 400 mg twice a day: 1200 mg orally once a day

Maximum dose:

-Oral suspension: 100 mg twice a day

-Chewable tablets: 300 mg twice a day

Comments:

-Neonates: If the mother used this drug 2 to 24 hours before delivery, the neonate’s first dose should be administered between 24 and 48 hours after birth.

-Neonates, birth to 1 week of age: The dosing recommendations are based on about 1.5 mg/kg/dose.

-Neonates, 1 to 4 weeks of age: The dosing recommendations are based on about 3 mg/kg/dose.

-Pediatric patients at least 4 weeks of age: The weight-based dosing recommendation for the oral suspension and chewable tablets is based on about 6 mg/kg/dose twice a day.

-The oral suspension can be used as long as weight is less than 20 kg; either the oral suspension or the chewable tablet formulation can be used for weight between 11 and 20 kg.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for Nonoccupational Exposure

US CDC Recommendations:

ORAL SUSPENSION:

Pediatric patients at least 4 weeks of age:

-Weight 3 to less than 4 kg: 25 mg orally twice a day

-Weight 4 to less than 6 kg: 30 mg orally twice a day

-Weight 6 to less than 8 kg: 40 mg orally twice a day

-Weight 8 to less than 11 kg: 60 mg orally twice a day

-Weight 11 to less than 14 kg: 80 mg orally twice a day

-Weight 14 to less than 20 kg: 100 mg orally twice a day

CHEWABLE TABLETS:

-Weight 11 to less than 14 kg: 75 mg orally twice a day

-Weight 14 to less than 20 kg: 100 mg orally twice a day

-Weight 20 to less than 28 kg: 150 mg orally twice a day

-Weight 28 to less than 40 kg: 200 mg orally twice a day

-Weight at least 40 kg: 300 mg orally twice a day

FILM-COATED TABLETS 400 MG:

-Weight at least 25 kg: 400 mg orally twice a day

Maximum dose:

-Oral suspension: 100 mg twice a day

-Chewable tablets: 300 mg twice a day

Duration of therapy: 28 days

Comments:

-This drug is recommended as a component of a preferred (or alternative) 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection in children at least 4 weeks of age; if other alternatives are considered, this drug is recommended as a component in various regimens.

-A pediatric HIV-specialist should be consulted for neonates (aged 0 to 27 days).

-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

-The oral suspension can be used as long as weight is less than 20 kg; either the oral suspension or the chewable tablet formulation can be used for weight between 11 and 20 kg.

-Current guidelines should be consulted for additional information.

Precautions

This drug is not recommended for use in preterm neonates or pediatric patients weighing less than 2 kg.

How is Raltegravir available?

Raltegravir is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral tablet, chewable,
  • Oral granule for reconstitution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Raltegravir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 21, 2018 | Last Modified: April 21, 2018

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