AccessPak for HIV PEP Basic

Name: AccessPak for HIV PEP Basic

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

For the Consumer

Applies to emtricitabine / tenofovir: oral tablet

Along with its needed effects, emtricitabine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking emtricitabine / tenofovir:

More common
  • Blisters under the skin
  • body aches or pain
  • difficulty in breathing
  • ear and nasal congestion
  • fever and chills
  • loss of voice
  • pain or tenderness around the eyes and cheekbones
  • rash with flat lesions or small raised lesions on the skin
  • redness of the skin
  • runny nose
  • sore throat
  • spots on your skin resembling a blister or pimple
  • unusual tiredness or weakness
Less common
  • Blindness or vision changes
  • burning of the face or mouth
  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs
  • chest pain
  • clumsiness or unsteadiness
  • stabbing pain
  • weakness in the hands or feet
Incidence not known
  • Agitation
  • bloating
  • bloody or cloudy urine
  • bone pain
  • change in how much or how often you urinate
  • coma
  • confusion
  • constipation
  • cough
  • darkened urine
  • difficult or painful urination
  • difficulty in swallowing
  • fast heartbeat
  • fast, shallow breathing
  • general feeling of discomfort
  • increased blood pressure
  • increased thirst
  • indigestion
  • irritability
  • itching skin, hives, welts
  • lethargy
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramping
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • seizures
  • sleepiness
  • stomach pain
  • stupor
  • sudden decrease in the amount of urine
  • swelling of the face, fingers, hands, lower legs, or ankles
  • tightness in the chest
  • yellow eyes or skin

Some side effects of emtricitabine / tenofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Depression
  • diarrhea
  • nausea
Less common
  • Acidic or sour stomach
  • anxiety
  • back pain
  • belching
  • difficulty in moving
  • heartburn
  • joint pain
  • lack or loss of strength
  • pain
  • passing of gas
  • stomach upset
  • stuffy nose
  • sweating
  • swollen joints
  • tiredness
  • trouble sleeping
  • vomiting
  • weight loss

Usual Pediatric Dose for HIV Infection

Emtricitabine-tenofovir alafenamide:
12 years or older and at least 35 kg: Emtricitabine 200 mg-tenofovir alafenamide 25 mg (1 tablet) orally once a day

Emtricitabine-tenofovir DF:
17 to less than 22 kg: Emtricitabine 100 mg-tenofovir DF 150 mg (1 tablet) orally once a day
22 to less than 28 kg: Emtricitabine 133 mg-tenofovir DF 200 mg (1 tablet) orally once a day
28 to less than 35 kg: Emtricitabine 167 mg-tenofovir DF 250 mg (1 tablet) orally once a day
At least 35 kg: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting emtricitabine-tenofovir alafenamide and should be monitored during therapy.
-Emtricitabine-tenofovir DF is recommended for pediatric patients who can swallow a whole tablet.
-Emtricitabine-tenofovir DF is not recommended as a component of a triple nucleoside regimen; it should not be used with other emtricitabine-containing, tenofovir-containing, or lamivudine-containing products.
-Use of emtricitabine-tenofovir DF in therapy-experienced patients should be guided by laboratory testing and treatment history.

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

Usual Pediatric Dose for Nonoccupational Exposure

US CDC recommendations for adolescents 13 years or older: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus (raltegravir or dolutegravir) is recommended as the preferred regimen for nonoccupational postexposure prophylaxis of HIV infection in adolescents with CrCl at least 60 mL/min; this drug plus darunavir/ritonavir is recommended as an alternative regimen for such patients. 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.

Liver Dose Adjustments

Emtricitabine-tenofovir alafenamide:
-Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
-Severe liver dysfunction (Child-Pugh C): Data not available

Emtricitabine-tenofovir DF: Data not available

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for emtricitabine-tenofovir DF for a preexposure prophylaxis indication. It includes elements to assure safe use. For additional information: www.fda.gov/REMS

US BOXED WARNINGS:
-LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs in combination with other antiretrovirals.
-POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: This drug is not approved for treatment of chronic HBV infection; safety and efficacy not established in patients infected with HBV (including those coinfected with HBV and HIV-1). Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping products containing emtricitabine and/or tenofovir DF, and may occur when tenofovir alafenamide-containing products are stopped. Hepatic function of HBV-infected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.
-DRUG RESISTANCE RISK WITH PREEXPOSURE PROPHYLAXIS USE IN UNDIAGNOSED HIV-1 INFECTION: Emtricitabine-tenofovir DF for preexposure prophylaxis (PrEP) must only be prescribed to individuals confirmed to be HIV-negative immediately before starting and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants identified with use of this drug for PrEP after undetected acute HIV-1 infection. This drug should not be started for a PrEP indication if signs/symptoms of acute HIV-1 infection are present unless negative infection status confirmed.

Emtricitabine-tenofovir alafenamide: Safety and efficacy have not been established in patients younger than 12 years or weighing less than 35 kg.

Emtricitabine-tenofovir DF:
-HIV-1 infection: Safety and efficacy have not been established in patients weighing less than 17 kg; since it is a fixed-dose combination tablet, this drug cannot be adjusted for these patients.
-PrEP: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Emtricitabine-tenofovir alafenamide: Data not available
Emtricitabine-tenofovir DF: Not recommended.

Emtricitabine / tenofovir Pregnancy Warnings

Animal studies have failed to reveal evidence of embryofetal toxicity, reproductive toxicity, or teratogenicity. There are no controlled data in human pregnancy; however, emtricitabine-tenofovir DF has been evaluated in a limited number of women during pregnancy and postpartum. Available human data suggest emtricitabine-tenofovir DF does not increase risk of major birth defects overall compared to background rate; data in pregnant women (between 300 to 1000 outcomes) showed no malformations, fetotoxicity, or neonatal toxicity with emtricitabine and tenofovir DF. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com The APR has received prospective reports of over 2900 exposures to emtricitabine-containing regimens (over 1900 exposed in the first trimester; over 900 exposed in the second/third trimester) and over 3800 exposures to tenofovir DF-containing regimens (over 2600 exposed in the first trimester; over 1200 exposed in the second/third trimester) resulting in live births; there was no difference between emtricitabine or tenofovir DF and overall birth defects compared with the background birth defect rate of 2.7% in the reference population. The prevalence of defects in the first trimester was 2.4% for emtricitabine and 2.3% for tenofovir DF. The prevalence of defects in the second/third trimester was 2.1% for emtricitabine and 2.1% for tenofovir DF. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Treatment of HIV Infection: This drug should be used during pregnancy only if clearly needed. Preexposure Prophylaxis: If an uninfected individual becomes pregnant while using emtricitabine-tenofovir disoproxil fumarate (DF), continued use should be carefully considered, taking into account the potential increased risk of HIV-1 infection during pregnancy. AU TGA pregnancy category: B3 US FDA pregnancy category: -Emtricitabine-tenofovir alafenamide: Not assigned. -Emtricitabine-tenofovir DF: B Risk summary (emtricitabine-tenofovir alafenamide): Insufficient data available on use of this drug in pregnant women to inform a drug-related risk of birth defects and miscarriage. Comments: -A pregnancy exposure registry is available.

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