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  • Selzentry maraviroc - Pfizer Inc.

    Selzentry: Black Box Warnings

    Hepatotoxicity
    hepatotoxicity has been reported; may present w/ allergic rxn incl. rash, eosinophilia, incr. IgE; evaluate immed. if hepatitis or allergic rxn signs/sx

    Selzentry: Adult Dosing

    Dosage forms: 150,300
    HIV infxn, CCR5-tropic
    combo w/ no CYP3A strong inhibitors or CYP3A inducers
    Dose: 300 mg PO bid; Info: see Drug Interactions for specific drugs; for tx-experienced pts; tropism testing required before tx
    combo w/ CYP3A strong inhibitor
    Dose: 150 mg PO bid; Info: see Drug Interactions for specific drugs; for tx-experienced pts; tropism testing required before tx
    combo w/ CYP3A inducer
    Dose: 600 mg PO bid; Info: see Drug Interactions for specific drugs; for tx-experienced pts; tropism testing required before tx
    combo w/ both CYP3A strong inhibitor and CYP3A inducer
    Dose: 150 mg PO bid; Info: see Drug Interactions for specific drugs; for tx-experienced pts; tropism testing required before tx
    renal dosing
    not defined
    hepatic dosing
    not defined

    Selzentry: Peds Dosing

    This information is currently unavailable or not applicable for this drug.

    Selzentry: Contraindications/Cautions

    • hypersens. to drug/class/compon.
    • CXCR4-tropic or dual/mixed HIV infxn
    • caution if cardiac risk factors
    • caution if orthostatic hypotension
    • caution if impaired renal fxn
    • caution if impaired liver fxn
    • caution in elderly pts

    Selzentry: Drug Interactions

    Contraindicated


    Monitor/Modify Tx


    Caution Advised

    Selzentry: Adverse Reactions

    Serious Reactions
    • hepatotoxicity
    • myocardial ischemia/infarction
    • hypotension, orthostatic
    • immune reconstitution syndrome
    • infection
    • malignancy
    Common Reactions
    • constipation/diarrhea/flatulence
    • URI
    • infection
    • nausea
    • headache
    • fatigue
    • cough
    • pruritus/rash
    • weight loss/decr. appetite
    • dizziness
    • arthralgia/myalgia
    • abdominal pain
    • insomnia
    • elevated liver transaminases
    • paresthesia/hypoesthesia
    • back pain
    • depression
    • HTN
    • dermatitis
    • dysgeusia
    • anxiety
    • lipodystrophy
    • extremity pain
    • dysuria
    • dyspnea
    • dyspepsia
    • asthenia
    • stomatitis
    • peripheral neuropathy
    • elevated CK

    Selzentry: Safety Monitoring

    Pregnancy: B
    Lactation: Unsafe
    Monitoring Parameters: no routine tests recommended

    Selzentry: Pharmacology

    Metabolism: liver 63-67%; CYP450: 3A substrate
    Excretion: feces 76% (25% unchanged), urine 20% (8% unchanged); Half-life 14-18h
    Class: Anti-Virals, HIV
    Mechanism Of Action
    binds to human CCR5 receptors, blocking HIV gp120 attachment and preventing cell entry

    Selzentry: Manufacturer/Pricing

     
    Manufacturer: Pfizer Inc.
    DEA/FDA: Rx

    Selzentry: Patient Education

    • Generic Name: maraviroc
    • Pronounced: ma RAV i rok
    • Brand Name: Selzentry
    What is the most important information I should know about maraviroc?

    There are many other medicines that can interact with maraviroc. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

    HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

    Taking maraviroc will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

    What is maraviroc?

    Maraviroc is an antiviral medication that prevents certain viral cells from multiplying in your body.

    Maraviroc is used to treat CCR5-tropic human immunodeficiency virus (HIV) type 1.

    Maraviroc is not a cure for HIV or AIDS.

    Maraviroc may also be used for purposes not listed in this medication guide.

    What should I discuss with my health care provider before taking maraviroc?

    Before using maraviroc, tell your doctor if you are allergic to any drugs, or if you have:

    • kidney disease;
    • liver disease, especially hepatitis B or C;
    • low blood pressure;
    • heart disease; or
    • circulation problems or a history of stroke.

    If you have any of these conditions, you may need dose adjustments or special tests during treatment. Your doctor will tell you if any of your medication doses need to be changed.

    FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

    You should not breast-feed while you are using maraviroc. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

    How should I take maraviroc?

    Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

    You may take maraviroc with or without food.

    Do not crush, chew, or break the maraviroc tablet. Swallow the pill whole.

    It is important to use maraviroc 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 different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

    Store maraviroc at room temperature away from moisture and heat.

    What happens if I miss a dose?

    Take the missed dose as soon as you remember and take your next dose at the regularly scheduled time. If you are more than 6 hours late in taking your maraviroc, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention if you think you have used too much of this medicine.

    Overdose symptoms may include feeling like you might pass out.

    What should I avoid while taking maraviroc?

    Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using maraviroc.

    What are the possible side effects of maraviroc?

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Stop using maraviroc and call your doctor at once if you have any of these serious side effects:

    • nausea, stomach pain, loss of appetite, skin rash, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
    • chest pain;
    • feeling like you might pass out;
    • cold sores, sores on your genital or anal area;
    • signs of a new infection, such as fever or chills, cough, or flu symptoms.

    Less serious side effects may include:

    • swelling;
    • white patches or sores inside your mouth or on your lips;
    • problems with urination;
    • runny or stuffy nose, sneezing, sore throat;
    • stomach pain, diarrhea;
    • muscle or joint pain;
    • dizziness; or
    • mild skin rash.

    This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

    What other drugs will affect maraviroc?

    The following drugs can interact with maraviroc. Tell your doctor if you are using any of these:

    • enfuvirtide (Fuzeon);
    • rifampin (Rifadin, Rimactane, Rifater);
    • St. John's wort;
    • seizure medication such as carbamazepine (Carbatrol, Tegretol) or this drug (Dilantin);
    • HIV /AIDS medicine such as amprenavir (Agenerase), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase, Fortovase);
    • antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), ketoconazole (Nizoral), or telithromycin (Ketek);
    • heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac) or verapamil (Calan, Covera, Isoptin, Verelan);

    This list is not complete and there may be other drugs that can interact with maraviroc. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

    Where can I get more information?

    Your pharmacist can provide more information about maraviroc.


    Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

    Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

    The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Selzentry: Pill Pictures

    This information is currently unavailable or not applicable for this drug.

     


    Copyright 1996-2006 Cerner Multum, Inc. Version: 5.05. Revision Date: 10/09/2007
    Last Updated: 10/09/2007


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