raltegravir (Rx)

Brand and Other Names:Isentress, Isentress HD
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, film-coated

  • 400mg (Isentress)
  • 600mg (Isentress HD)

HIV-1 Infection

Indicated in combination with other antiretroviral agents for HIV-1 infection

Also see Administration

Treatment-naïve or virologically suppressed

  • Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of 400 mg BID
  • Isentress (400-mg tab): 400 mg PO BID
  • Isentress HD (600-mg tab): 1200 (two 600-mg tabs) PO qDay

Treatment-experienced

  • 400 mg PO BID

Dosage Modifications

Coadministration with rifampin

  • Treatment-naïve or treatment-experienced when coadministered with rifampin
  • 800 mg (two 400-mg tabs) PO BID

Hepatic impairment

  • Isentress
    • Mild-to-moderate (Child Pugh A and B): No dose adjustment required
    • Severe (Child Pugh C): Not studied
  • Isentress HD
    • Safety and efficacy not established; administration is not recommended

Renal impairment

  • No dosage adjustment required for any degree of renal impairment
  • Dialysis: Unknown if drug is removed by dialysis; avoid dosing before dialysis session

Dosing Considerations

Combination regimen is based on analyses of plasma HIV-1 RNA levels in 3 double-blind controlled studies; 2 of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults through 96 wk and 1 study was conducted in treatment-naïve adults through 240 wk

The use of other active agents with raltegravir is associated with a greater likelihood of treatment response

Do not substitute chewable tablets or oral suspension for film-coated tablets; these are not bioequivalent, and therefore, are not interchangeable

Do not switch between film-coated 400 mg and 600 mg tablet if prescribed dose is 1200 mg

Dosage Forms & Strengths

tablet, film-coated

  • 400mg (Isentress)
  • 600mg (Isentress HD)

tablet, chewable

  • 25mg
  • 100mg (scored)

powder for oral suspension

  • 100mg/packet

HIV-1 Infection

Film-coated tablet, Isentress 400-mg tab

  • Indicated in combination with other antiretroviral agents for HIV-1 infection in adults and children weighing at least 2 kg
  • ≥25 kg to <40 kg: 400 mg PO BID
  • ≥40 kg and treatment naïve or virologically suppressed on an initial regimen: 400 mg PO BID

Film-coated tablet, Isentress HD 600-mg tab

  • Indicated in combination with other antiretroviral agents for HIV-1 infection in adults and children weighing at least 40 kg
  • ≥40 kg and treatment naïve or virologically suppressed on an initial regimen:1200 mg PO qDay

Chewable tablet, Isentress 25 mg- or 100-mg tab

  • <4 weeks: Safety and efficacy not established; not recommended in preterm neonates
  • ≥4 weeks
    • Not to exceed daily dose is 300 mg PO BID; dosing recommendations are based on ~6 mg/kg/dose
    • 11 to <14 kg: 75 mg PO BID (3 x 25 mg tablets)
    • 14 to <20 kg: 100 mg PO BID (1 x 100 mg tablet)
    • 20 to <28 kg: 150 mg PO BID (1.5 x 100 mg tablets)
    • 28 to <40 kg: 200 mg PO BID (2 x 100 mg tablet)
    • ≥40 kg: 300 mg PO BID (3 x 100 mg tablets)

Oral suspension

  • Not to exceed 100 mg PO BID; see age and weight-based dosing listed below
  • Preterm neonates: Safety and efficacy not established
  • For full-term neonates (birth to 1 week)
    • Dosing recommendations are based on ~1.5 mg/kg/dose
    • 2 to <3 kg: 4 mg (0.4 mL) PO qDay
    • 3 to <4 kg: 5 mg (0.5 mL) PO qDay
    • 4 to <5 kg: 7 mg (0.7 mL) PO qDay
  • For full-term neonates (1 to 4 weeks)
    • Dosing recommendations are based on ~3 mg/kg/dose
    • 2 to <3 kg: 8 mg (0.8 mL) PO qDay
    • 3 to <4 kg: 10 mg (1 mL) PO qDay
    • 4 to <5 kg: 15 mg (1.5 mL) PO qDay
  • Age at least 4 weeks and weight 3-20 kg
    • 3 to <4 kg: 25 mg (2.5 mL) PO BID
    • 4 to <6 kg: 30 mg (3 mL) PO BID
    • 6 to <8 kg: 40 mg (4 mL) PO BID
    • 8 to <11 kg: 60 mg (6 mL) PO BID
    • 11 to <14 kg: 80 mg (8 mL) PO BID
    • 14 kg to <20 kg: 100 mg (10 mL) PO BID

Dosage Modifications

Hepatic impairment

  • Isentress
    • Mild-to-moderate (Child Pugh A and B): No dose adjustment required
    • Severe (Child Pugh C): Not studied
  • Isentress HD
    • Safety and efficacy not established; administration is not recommended

Renal impairment

  • No dosage adjustment required for any degree of renal impairment
  • Dialysis: Unknown if drug is removed by dialysis; avoid dosing before dialysis session

Dosing Considerations

Combination regimen is based on safety, tolerability, pharmacokinetic parameters, and efficacy data through at least 24-wk in a multicenter, open-label, noncomparative study in HIV-1 infected children and adolescents aged 4 wk to 18 yr

Do not substitute chewable tablets or oral suspension for film-coated tablets; these are not bioequivalent, and therefore, are not interchangeable

Do not switch between film-coated 400 mg and 600 mg tablet if prescribed dose is 1200 mg

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Interactions

Interaction Checker

and raltegravir

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (5)

            • aluminum hydroxide

              aluminum hydroxide decreases levels of raltegravir by cation binding in GI tract. Contraindicated. Not recommended with or without dose separation.

            • aluminum hydroxide/magnesium carbonate

              aluminum hydroxide/magnesium carbonate will decrease the level or effect of raltegravir by enhancing GI absorption. Applies only to oral form of both agents. Contraindicated. Not recommended with or without dose separation

            • aluminum hydroxide/magnesium trisilicate

              aluminum hydroxide/magnesium trisilicate will decrease the level or effect of raltegravir by enhancing GI absorption. Applies only to oral form of both agents. Contraindicated. Not recommended with or without dose separation

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              raltegravir, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.

            • magnesium supplement

              magnesium supplement will decrease the level or effect of raltegravir by Other (see comment). Contraindicated. Drug may form a chelate with polyvalent cations; may decrease absorption by the intestinal tract; applies to oral forms

            Serious - Use Alternative (4)

            • cabotegravir

              raltegravir, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.

            • magnesium hydroxide

              magnesium hydroxide will decrease the level or effect of raltegravir by cation binding in GI tract. Avoid or Use Alternate Drug. Magnesium containing antacids reduce raltegravir plasma levels when taken within 6 hr of raltegravir dose

            • sodium sulfate/?magnesium sulfate/potassium chloride

              sodium sulfate/?magnesium sulfate/potassium chloride decreases levels of raltegravir by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            • sodium sulfate/potassium sulfate/magnesium sulfate

              sodium sulfate/potassium sulfate/magnesium sulfate decreases levels of raltegravir by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

            Monitor Closely (9)

            • apalutamide

              apalutamide will decrease the level or effect of raltegravir by increasing elimination. Use Caution/Monitor. Apalutamide induces UGT and may decrease systemic exposure of drugs that are UGT substrates.

            • fosamprenavir

              fosamprenavir will decrease the level or effect of raltegravir by unknown mechanism. Use Caution/Monitor.

            • nirmatrelvir

              nirmatrelvir will decrease the level or effect of raltegravir by Other (see comment). Use Caution/Monitor. Raltegravir is an UGT1A1 substrate. Ritonavir induces UGT 1A1.

            • orlistat

              orlistat will decrease the level or effect of raltegravir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

            • rifabutin

              rifabutin will decrease the level or effect of raltegravir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Rifabutin induces UGT1A1

            • rifampin

              rifampin decreases levels of raltegravir by increasing hepatic clearance. Use Caution/Monitor.

            • selenium

              selenium will decrease the level or effect of raltegravir by cation binding in GI tract. Modify Therapy/Monitor Closely. Administer raltegravir at least 2 h before or 6 h after polyvalent cations. Note: Dose separation may not adequately avoid this interaction.

            • sodium zirconium cyclosilicate

              sodium zirconium cyclosilicate will increase the level or effect of raltegravir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

            • zinc

              zinc will decrease the level or effect of raltegravir by cation binding in GI tract. Modify Therapy/Monitor Closely. Administer raltegravir 2 hr before or 6 hr after administration of polyvalent cation containing products.

            Minor (0)

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              Adverse Effects

              >10% (STARMARK trial)

              Serum alanine aminotransferase, Grade 2-4 (2-11%)

              Serum aspartate aminotransferase, Grade 2-4 (1-8%)

              1-10% (STARTMRK trial)

              Fasting serum glucose test, Grade 2-4 (7%)

              Total serum bilirubin, Grade 2-4 (≤5%)

              Headache (4%)

              Insomnia (4%)

              Nausea (3%)

              ANC, Grade 2-4 (1-3%)

              Serum alkaline phosphate, Grade 2-4 (≤3%)

              Dizziness (2%) Fatigue (2%)

              Creatinine (≤1%)

              Hemoglobin, Grade 2-4 (≤1%)

              Platelet count, Grade 2-3 (≤1%)

              1-10% (ONCEMRK trial)

              Lipase, Grade 2-4 (≤2-7%)

              Creatine kinase, Grade 2-4 (≤2-4%)

              Serum aspartate aminotransferase, Grade 2-4 (≤5%)

              Serum alanine aminotransferase, Grade 2-4 (≤4%)

              Serum alkaline phosphate, Grade 2-4 (≤1%)

              ANC, Grade 2-4 (≤2%)

              Platelet count, Grade 2-3 (≤1%)

              Total serum bilirubin, Grade 2-4 (≤3%)

              Headache (1%)

              Nausea (1%)

              Postmarketing Reports

              Blood and lymphatic system disorders: Thrombocytopenia

              Gastrointestinal Disorders: Diarrhea

              Hepatobiliary disorders: Hepatic failure (with and without associated hypersensitivity) in patients with underlying liver disease and/or concomitant medications

              Musculoskeletal and connective tissue disorders: Rhabdomyolysis

              Nervous system disorders: Cerebellar ataxia

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              Warnings

              Contraindications

              None

              Cautions

              Risk of immune reconstitution syndrome if used with HAART; during 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 (eg, Graves disease, polymyositis, Guillain-Barré syndrome) reported in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment

              Concomitant medications known to increase risk of myopathy or rhabdomyolysis

              Coadministration with drugs that are strong inducers of UGT1A1 may result in reduced plasma concentrations of raltegravir

              Drug rash with eosinophilia and systemic symptoms (DRESS) reported

              Severe, potentially life-threatening and fatal skin reactions reported; skin reactions include cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis; immediately discontinue treatment if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely

              Chewable tablets contain phenylalanine, a component of aspartame; phenylalanine can be harmful to patients with phenylketonuria

              Drug interactions overview

              • Coadministration of raltegravir with drugs that inhibit UGT1A1 (eg, rifampin) may reduce plasma levels of raltegravir (see Dosage Modifications)
              • Coadministration with other strong inducers (eg, carbamazepine, phenobarbital, phenytoin) of drug-metabolizing enzymes on raltegravir is unknown and therefore not recommended
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              Pregnancy & Lactation

              Pregnancy

              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

              Available data from APR show no difference in rate of overall birth defects for raltegravir compared to background rate for major birth defects of 2.7% in U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP); the rate of miscarriage is not reported in the APR; 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

              In animal reproduction studies in rats and rabbits, no evidence of adverse developmental outcomes observed with oral administration during organogenesis at doses that produced exposures up to approximately 4 times maximal recommended human dose (MRHD) of 1200 mg

              Lactation

              The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection

              No data are available on presence of raltegravir in human milk, effects on breastfed infant, or on milk production; when administered to lactating rats, raltegravir was present in milk

              Owing to the potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV- positive infants), and adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving therapy

              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

              Inhibits catalytic activity of HIV-1 integrase, an HIV encoded enzyme required for viral replication

              Absorption

              Fasted state

              • Peak plasma concentration: 4.5 mcg/mL (400 mg PO BID and 1200 mg PO qDay)
              • Peak plasma time: ~3 hr (400 mg PO BID)
              • Peak plasma time: ~1.5 – 2 hr (1200 mg PO qDay)
              • Steady state: 2 days

              Effect of food

              • Low fat
                • AUC ratio: 0.54 (400 mg PO BID); 0.58 (1200 mg PO BID)
                • Peak plasma concentration ratio: 0.48 (400 mg PO BID); 0.48 (1200 mg PO qDay)
              • Moderate fat
                • AUC ratio: 1.13 (400 mg PO BID)
                • Peak plasma concentration ratio: 1.05 (400 mg PO BID)
              • High fat
                • AUC ratio: 2.11 (400 mg PO BID); 1.02 (1200 mg PO BID); 0.94 (chewable tablet)
                • Peak plasma concentration ratio: 1.96 (400 mg PO BID); 0.72 (1200 mg PO qDay); 0.38 (chewable tablet)

              Distribution

              Protein Bound: ~83%

              Metabolism

              Primarily metabolized by UGT1A1-mediated glucuronidation

              Elimination

              Half-Life: ~9 hr

              Excretion: 51% (feces); 32% (urine)

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              Administration

              Oral Suspension Preparation

              Combine and mix 10 mL of water and 1 packet (100 mg) of the oral suspension

              Gently swirl mixing cup for 45 seconds in a circular motion to mix powder into a uniform suspension; final concentration (10 mg/mL); do not shake

              Once mixed, measure prescribed dose volume with a syringe and administer the dose orally

              Administer dose within 30 minutes of mixing

              Discard any remaining suspension into the trash

              Oral Administration

              May administer with or without food

              Do not substitute chewable tablets or oral suspension for film-coated tablets; these are not bioequivalent, and therefore, are not interchangeable

              Film-coated tablet: Must be swallowed whole

              Chewable tablet

              • May be chewed or swallowed whole
              • Preparation of crushed 25-mg chewable tablets for patients who difficulty chewing tablets
                • Place tablet(s) in a small, clean cup
                • For each tablet, add a teaspoonful (~5 mL) of liquid (eg, water, juice, breast milk)
                • Within 2 minutes, tablet(s) will absorb the liquid and fall apart
                • Using a spoon, crush any remaining pieces of the tablet(s)
                • Immediately administer the entire dose orally
                • If any portion of the dose is left in the cup, add another teaspoonful (~5 mL) of liquid, swirl and administer immediately

              Storage

              Oral suspension

              • Store at room temperature between 68-77ºF (20-25ºC)
              • Store in the original container
              • Do not open foil packet until ready for use

              Chewable tablets

              • Store at room temperature between 68-77°F (20-25°C)
              • Store in the original package with the bottle tightly closed
              • Keep the drying agent (desiccant) in bottle to protect from moisture

              Film-coated tablets

              • Store at room temperature between 68-77°F (20-25°C)
              • Store in the original package with the bottle tightly closed
              • Keep the drying agent (desiccant) in bottle to protect from moisture
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Isentress HD oral
              -
              600 mg tablet
              Isentress oral
              -
              400 mg tablet
              Isentress oral
              -
              100 mg powder
              Isentress oral
              -
              100 mg chewable tablet
              Isentress oral
              -
              100 mg powder
              Isentress oral
              -
              100 mg powder

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              raltegravir oral

              RALTEGRAVIR POWDER PACKET - ORAL

              (ral-TEG-ra-vir)

              COMMON BRAND NAME(S): Isentress

              USES: This formulation of raltegravir is used with other HIV medications for infants and children to help control HIV infection. It helps to decrease the amount of HIV in the body so your child's immune system can work better. This lowers the chance of getting HIV complications (such as new infections, cancer) and improves your child's quality of life. Raltegravir belongs to a class of drugs known as integrase inhibitors. It blocks the virus from growing and infecting more cells.Raltegravir is not a cure for HIV infection. To decrease the risk of spreading HIV disease to others, your child should continue to take all HIV medications exactly as prescribed by the doctor. Do not share your child's personal items (such as needles/syringes, toothbrushes) that may have contacted blood or other body fluids. Consult the doctor or pharmacist for more details.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start giving raltegravir to your child and each time you get a refill. If you have any questions, ask the doctor or pharmacist.Give this medication to your child by mouth with or without food as directed by the doctor, usually once or twice daily. The dosage is based on your child's medical condition, response to treatment, age, weight, and other medications your child may be taking. Be sure to tell the doctor and pharmacist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).Empty the contents of one packet in the mixing cup. Measure the amount of water as directed using the syringe and add it to the mixing cup. Mix well by gently swirling the cup. Do not shake. Measure the dose using the syringe. Do not use a household spoon because you may not get the correct dose. Give the dose within 30 minutes after mixing.Avoid using antacids that contain aluminum or magnesium while taking this medication. These antacids can make raltegravir work less well.It is very important to continue giving this medication (and other HIV medications) exactly as prescribed by the doctor. Do not skip any doses.Do not increase the dose or give this drug more often or for longer than prescribed. Your child's condition will not improve any faster, and the risk of side effects will increase.Do not give more or less of this drug than prescribed or stop giving it (or other HIV medicines) even for a short time unless directed to do so by the doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time(s) every day.Do not switch between the film-coated tablet, the chewable tablet, or the powder packet for oral suspension forms of raltegravir without asking your doctor or pharmacist first.

              SIDE EFFECTS: Headache, nausea, or trouble sleeping may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.As your child's immune system gets stronger, it can begin to fight off infections they already had, possibly causing disease symptoms to come back. Your child could also have symptoms if their 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 your child has 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 unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).Tell the doctor right away if your child has 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 your child is 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 the 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, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking raltegravir, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell the doctor or pharmacist your child's 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 the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).This formulation of raltegravir is not usually used by adults. It is unlikely to be used during pregnancy or breast-feeding. Consult the doctor if you have any questions about this medication.

              DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.A product that may interact with this drug is: orlistat.If you are breast-feeding your child, ask the doctor if any medications that you are using may pass into the breast milk and interact with this medication.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as viral load, T-cell counts) should be performed periodically to monitor your child's progress or check for side effects. Consult the doctor for more details.Keep all regular medical and laboratory appointments.

              MISSED DOSE: If you miss a dose, give it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Give the next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store in the original container at room temperature away from light and moisture. Once it has been mixed, discard any portion you do not use. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.
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              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.
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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.