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    更新日: 2025.01.07
    Medical Information: Alafevir EM

    Important safety information including dosage, side effects, and precautions of Alafevir EM

    Dosage & Administration

    ・Take one tablet daily, preferably at same time each day.

    Side Effects

    Main Side Effects


    The following side effects may occur with use of Alafevir EM. In most cases, they will subside over time. However, if you notice any abnormalities, discontinue use and take appropriate measures.

    • ・Diarrhea (the most common side effect reported in HIV-1 PrEP trials)
    • ・Nausea
    • ・Headache
    • ・Fatigue
    • ・Stomach pain
    • ・Weight changes



    Serious Side Effects – seek immediate medical attention:

    If you experience any of the following serious side effects, stop taking the medication and consult your doctor immediately:

    • ・Immune Reconstitution Syndrome
    • ・Kidney Problems


    • ・Lactic Acidosis (a rare but severe condition caused by excessive lactic acid in the blood that may occur, with symptoms such as the following):
    • ●Unusual fatigue or weakness
    • ●Muscle pain
    • ●Shortness of breath or rapid breathing
    • ●Stomach pain, nausea, or vomiting
    • ●Cold or bluish limbs
    • ●Dizziness or irregular heartbeat


    ・Severe Liver Damage (rare but potentially leading to liver failure), with symptoms such as:

    • ●Yellowing of the skin or eyes
    • ●Dark brown urine
    • ●Pale stool
    • ●Loss of appetite
    • ●Persistent nausea or stomach pain


    • ・Worsening of Hepatitis B (HBV)

    Precautions

    ・This medication has been prescribed specifically for you. Do not share it with others.

    ・If you need to visit a doctor or hospital while using this medication, inform them that you are taking it.

    ・Always follow the prescribed dosage instructions carefully.



    1.　Patients who should use with caution:

    （1）HIV Status:

    Only for individuals confirmed to be HIV-negative.

    （2）Hepatitus B: 

    Take caution if you have HBV, as stopping the medication can worsen the infection.

    （3）Kidney dysfunction:

    Monitor kidney function regularly, particularly if you have renal issues.

    （4）High-risk individuals:

     Patients at increased risk for HIV-1 exposure should be evaluated carefully.

    （5）Immune reconstitution syndrome:

    Caution in those with a history of IRIS.


    2.　Medication to use with caution:

    ・Antiretroviral agents: protease inhibitors (PI)

    Tipranavir / Ritonavir

    ・Anticonvulsants

    Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin

    ・ Antimycobacterials

    Rifabutin, Rifampin, Rifapentine

    ・Herbal Products

    St. John's Wort (Hypericum perforatum)


    3.　Storage and shelf life

    ・Store between 20°C and 25°C (68°F to 77°F).

    ・Keep in its original container and tightly closed.

    ・Keep out of the reach of children.

    Approval Status in Japan

    ・PrEP is not approved in Japan.


    *Medications prescribed under this treatment category are not covered by the Pharmaceutical Side Effect Relief System.

    Availability of approved medicines that have the same active ingredients in Japan

    ・In Japan, Descovy contains the same active ingredient, but it is not approved for use as PrEP.

    Means of Acquisition

    ・The medication is purchased through a domestic pharmaceutical distributor by a doctors at affiliated clinics.

    Information on safety and approval in other countries

    ・The U.S. Food and Drug Administration (FDA) has approved the brand-name medication Descovy for PrEP.

    ・No serious safety concerns have been reported in other countries.