AccessPak for HIV PEP Basic

Name: AccessPak for HIV PEP Basic

What is the most important information I should know about AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Do not take emtricitabine and tenofovir if you also take other medicines that contain emtricitabine, tenofovir, lamivudine, or adefovir.

Emtricitabine and tenofovir is sometimes used to reduce the risk of becoming infected with HIV. You must be HIV-negative to use emtricitabine and tenofovir for this purpose.

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping.

What should I discuss with my healthcare provider before taking AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

You should not take this medicine if you are allergic to emtricitabine or tenofovir. Do not take if you also use other medicines that contain emtricitabine, tenofovir, lamivudine, or adefovir (such as Atripla, Combivir, Complera, Descovy, Dutrebis, Emtriva, Epivir, Epzicom, Genvoya, Hepsera, Odefsey, Stribild, Triumeq, Trizivir, or Viread).

Do not take Truvada to reduce infection risk if you are HIV-positive, if have been exposed to HIV within the past month, or if you had any symptoms (such as fever, sore throat, night sweats, swollen glands, diarrhea, body aches).

If you take Truvada to reduce your risk of HIV infection: You must have a negative HIV test immediately before you start taking the medicine. An HIV test is also required every 3 months during treatment.

To make sure this medicine is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • osteopenia (low bone mineral density); or

  • if you also have hepatitis B infection.

Some people taking this medicine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

You should not breast-feed while you are using this medication to treat or prevent HIV. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Emtricitabine and tenofovir is not approved for anyone younger than 12 years old. The child receiving this medicine must weigh at least 37 pounds.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What other drugs will affect AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • chemotherapy, injected antibiotics, injectable osteoporosis medications, medicine for bowel disorders, medicine to prevent organ transplant rejection;

  • antiviral medicine to treat hepatitis C--ledipasvir, sofosbuvir, velpatasvir;

  • other HIV medications--atazanavir, darunavir, didanosine, lopinavir, ritonavir; or

  • some pain or arthritis medicines--aspirin, Tylenol, Advil, and Aleve.

This list is not complete. Other drugs may interact with emtricitabine and tenofovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations: Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally once a day
Duration of therapy: 28 days, if tolerated

-This drug plus raltegravir 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.

Renal Dose Adjustments

Emtricitabine-tenofovir alafenamide:
-Severe renal dysfunction (estimated CrCl less than 30 mL/min): Not recommended.

Emtricitabine-tenofovir DF:
Treatment of HIV-1 Infection:
-Mild renal dysfunction (CrCl 50 to 80 mL/min): No adjustment recommended.
-Moderate renal dysfunction (CrCl 30 to 49 mL/min): Emtricitabine 200 mg-tenofovir DF 300 mg (1 tablet) orally every 48 hours
-Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

Pediatric patients: Data not available

Preexposure Prophylaxis:
-Estimated CrCl less than 60 mL/min: Not recommended.

Comments (emtricitabine-tenofovir DF):
-Routine monitoring of estimated CrCl, serum phosphorus, urine glucose, and urine protein recommended for all patients (with or without HIV-1 infection) with mild renal dysfunction.
-Safety and efficacy of the dosing interval adjustment have not been clinically evaluated in patients with moderate renal dysfunction; clinical response to therapy and renal function should be closely monitored in these patients.
-If estimated CrCl decreases during preexposure prophylaxis, potential causes should be evaluated and potential risks and benefits of continued use should be reassessed.

Emtricitabine / tenofovir Breastfeeding Warnings

EMTRICITABINE: Samples of breast milk obtained from 5 HIV-1-infected women show that emtricitabine is secreted in human milk. Average peak and trough drug levels in breast milk were 679 and 177 mcg/L, respectively. An exclusively breastfed infant would receive about 2% of the proposed emtricitabine dose for infants (estimated). Breastfeeding infants whose mothers are treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. TENOFOVIR DF: Samples of breast milk obtained from 5 HIV-1-infected mothers show that tenofovir is secreted in human milk. Average peak and trough drug levels in breast milk were 14.1 and 6.8 mcg/L, respectively. An exclusively breastfed infant would receive about 0.03% of the proposed tenofovir dose for infants (estimated) and attain trivial infant serum levels. The impact of this exposure in infants breastfed by mothers treated with tenofovir is unknown. In a multicenter study, a single 600 or 900 mg tenofovir dose was administered to mothers during labor; samples of breast milk were collected at various times postpartum. In 75% of samples obtained from 25 mothers during the first 2 days postpartum, tenofovir was detected (greater than 2.5 mcg/L); levels ranged from 6.3 to 17.8 mcg/L. Only 1 of 21 milk samples had detectable tenofovir level (15.7 mcg/L) at 4 to 6 days postpartum. Tenofovir (dose not provided; presumed 300 mg/day), lamivudine, and efavirenz were administered daily (between 6 and 8 PM) for prevention of mother-to-child HIV transmission. At 1 month postpartum, milk samples were collected in the morning from 33 women; tenofovir level was 5 mcg/L (interquartile range [IQR]: 0 to 6.1 mcg/L). At 12 months postpartum, milk samples were collected in the morning from 47 women; tenofovir level was 2.5 mcg/L (IQR: 0 to 5.5 mcg/L). Blood samples were obtained from 25 of their breastfed infants; the morning infant plasma level of tenofovir at 6 and 12 months of age was 24 mcg/L (IQR: 0 to 51.6 mcg/L) and 0 mcg/L, respectively. Serum tenofovir levels were measured in 5 infants exclusively breastfed by 4 mothers using tenofovir 245 mg daily; infant age averaged 1.8 months. In 4 infants, serum tenofovir was undetectable (less than 0.005 mg/L); in 1 infant, the serum tenofovir was 0.0055 mg/L. At 4 months of age, no adverse outcomes (on standard developmental parameters) were observed in 2 of the infants exclusively breastfed for 3 months.

Breastfeeding is not recommended during use of this drug. If replacement feeding is not an option, the WHO recommends a triple-drug regimen for HIV-infected women who are nursing; emtricitabine and tenofovir disoproxil fumarate (DF) are included in the first-choice regimen. Emtricitabine-tenofovir alafenamide: -Excreted into human milk: Yes (emtricitabine); Unknown (tenofovir alafenamide) -Excreted into animal milk: Unknown (tenofovir alafenamide) Emtricitabine-tenofovir DF: -Excreted into human milk: Yes (emtricitabine, tenofovir) Comments: -The effects in the nursing infant are unknown; potential for HIV-infected infants developing viral resistance and breastfed infants developing side effects similar to those in adults -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. -Local guidelines should be consulted if replacement feeding is not an option.