Jamp-Efavirenz: Uses, Side Effects and Dosage

What is JAMP-Efavirenz?

• JAMP-Efavirenz is the brand name for the active ingredient efavirenz.
• JAMP-Efavirenz belongs to a class of anti-HIV medicines known as "non-nucleoside reverse transcriptase inhibitors" (NNRTIs or non-nukes).

What the medication is used for:

• Your doctor has prescribed JAMP-Efavirenz for you because you have been infected with HIV. JAMP-Efavirenz must always be taken in combination with other anti-HIV medicines (frequently referred to as "combination therapy").
• When taken with other anti-HIV medicines, efavirenz has been shown to reduce viral load and increase the number of CD4 cells (a type of immune cell in blood). Efavirenz may not have these effects in every patient.

Does JAMP-Efavirenz cure HIV or AIDS?

• JAMP-Efavirenz is not a cure for HIV nor Acquired Immunodeficiency Syndrome (AIDS). People taking JAMP-Efavirenz may still develop infections or other illnesses associated with HIV.
• It is very important that you remain under the constant care of your doctor while taking JAMP- Efavirenz.

Does JAMP-Efavirenz reduce the risk of passing HIV to others?

• JAMP-Efavirenz has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. It is important to continue to practice safe sex and not use or share dirty needles.

What it does:

• JAMP-Efavirenz fights Human Immunodeficiency Virus (HIV) infection by reducing the amount of

  virus in the blood (called "viral load").

When it should not be used:

• Do not take JAMP-Efavirenz if you know you are allergic to any of the ingredients in the JAMP- Efavirenz tablets (see What the nonmedicinal ingredients are).
• JAMP-Efavirenz should not be taken with some other medicines that are listed in this pamphlet (see the section entitled “Drugs that may interact with JAMP-Efavirenz”).

What the medicinal ingredient is: Efavirenz

What the nonmedicinal ingredients are:

• JAMP-Efavirenz tablets also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. The film coating contains hypromellose, iron oxide yellow, polyethylene glycol and titanium dioxide.

What dosage forms it comes in:

• Each JAMP-Efavirenz tablet contains 600 mg of efavirenz.

BEFORE TAKING JAMP-Efavirenz

What should I tell my doctor before I start JAMP- Efavirenz?

• Inform your doctor about any past or present medical problems, including liver disease, hepatitis, allergies, severe kidney failure, seizures or mental illness.
• Inform your doctor if you have ever had a previous life- threatening skin reaction (e.g. Stevens-Johnson syndrome).
• Inform your doctor about any medications (prescription and nonprescription), herbal products, vitamins, nutritional supplements that you are currently taking or are planning to take.
• Also inform your doctor about any recreational (street, illicit) drugs that you are currently taking or are planning to take. The effect of combining recreational (street, illicit) drugs or alcohol with efavirenz has not been studied. Because they may interact with each other, speak with your doctor or other healthcare provider before you combine these drugs.
• Inform your doctor if you have or have had a heart rhythm disorder such as an irregular heartbeat, prolongation of the QT interval or any risk factors

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

for Torsade de Pointes (dangerous fluttering of the heart).

What should I consider concerning contraception, pregnancy, or breast-feeding?

• Tell your doctor if you are pregnant or planning to become pregnant. Birth defects have been reported in the offsprings of animals and women treated with efavirenz during pregnancy. It is not known whether efavirenz caused these defects. Women should not become pregnant while taking JAMP- Efavirenz and for 12 weeks after stopping it. If you are pregnant, you should take JAMP- Efavirenz only if you and your doctor decide that the possible benefit to you is greater than the possible risk to your foetus. If you take JAMP- Efavirenz while you are pregnant, talk to your doctor about how you can be included in the antiretroviral pregnancy registry.
• Tell your doctor if you are breastfeeding or planning to breastfeed. It is currently recommended that HIV- infected women should not breastfeed. Discuss this with your doctor.
• A reliable form of barrier contraception must always be used even if you or your partner are using other methods of contraception such as the pill or other hormonal therapy (e.g., implants, injections). JAMP-Efavirenz may remain in your blood for a time after therapy is stopped. Therefore, you should continue use of a reliable form of contraception for 12 weeks after stopping treatment with JAMP-Efavirenz.

Can children take JAMP-Efavirenz?

• JAMP-Efavirenz has not been studied in children below 3 years of age.

Do not drive or operate machinery until you have determined your response to JAMP-Efavirenz, as this may make you sleepy or dizzy.

JAMP-Efavirenz can cause abnormal blood test results. Your doctor may perform blood tests and will interpret the results.

To find out how to take JAMP-Efavirenz please read carefully the following section “WHILE TAKING JAMP-Efavirenz”.

Drugs that may interact with JAMP-Efavirenz

JAMP-Efavirenz may affect the dosing of other medications including ones for treating HIV infection. For this reason it is very important to:

• Let all healthcare providers know that you are taking JAMP-Efavirenz.

  • Inform your doctor and pharmacist about all medications that you are currently taking including those obtained over-the-counter without a prescription and complementary medications (vitamins, nutritional supplements, etc.) and herbal products, particularly St. John’s Wort.
  • Consult your doctor or pharmacist before you start any new medication.
  • Consult your doctor or pharmacist before you stop any medications that you are currently taking.

Bring all your medications when you see your doctor. Or make a list of their names, how much you take, and how often you take them. This will give your doctor a complete picture of the medications you are taking. Then he or she can decide the best approach for your situation.

You must not take the following medications if you are taking JAMP-Efavirenz. Taking these medications with JAMP-Efavirenz could create the potential for serious and/or life-threatening side effects:

CISAPRIDE*^♦ MIDAZOLAM

TRIAZOLAM (e.g, HALCION*)

ERGOT MEDICATIONS (e.g, CAFERGOT*) PIMOZIDE (e.g, ORAP*)

ZEPATIER

ST. JOHN’S WORT (Hypericum perforatum)

You must not take products containing St. John’s wort (Hypericum perforatum) with JAMP-Efavirenz as this may stop JAMP-Efavirenz from working properly and may lead to resistance to JAMP-Efavirenz or resistance to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).

• ♦ CISAPRIDE is not marketed in Canada
• ♦

The following drugs may interact with JAMP- Efavirenz and your doctor will determine whether they can be used or not or may make dosage changes for JAMP-Efavirenz or the other product, or substitute other products, as indicated below:

• JAMP-Efavirenz may be taken with many of the medications commonly used in people with HIV infection. These include the protease inhibitors, such as nelfinavir (Viracept*) and indinavir (Crixivan*), and nucleoside analogue reverse transcriptase inhibitors (NRTIs).
• Use of JAMP-Efavirenz with saquinavir (Invirase*) is not recommended if you are taking saquinavir as your only protease inhibitor.
• VORICONAZOLE (VFEND*) should not be taken at standard doses with JAMP-Efavirenz

INTERACTIONS WITH THIS MEDICATION

• since it may lose its effect or increase the chance of side effects from efavirenz. Some doses of voriconazole can be taken at the same time as a lower dose of efavirenz, but your doctor will decide if this is appropriate.
• Tegretol* (carbamazepine), Sporanox* (itraconazole), Posanol* (posaconazole) and REYATAZ* (atazanavir sulfate), if this is not the first time you are receiving treatment for your HIV infection, may need to be replaced with another medicine when taken with JAMP- Efavirenz.
• JAMP-Efavirenz reduces the blood levels of clarithromycin (Biaxin*) and is associated with a higher incidence of rash; your doctor may consider giving you an alternative antibiotic.
• If you are taking JAMP-Efavirenz and REYATAZ* (atazanavir sulfate), you should also be taking Norvir* (ritonavir).
• JAMP-Efavirenz reduces exposure of Galexos* (simeprevir) and co-administration is not recommended; your doctor should consider alternatives.
• Antimalarials such as atovaquone/proguanil, when taken with efavirenz, may reduce the amount of atovaquone/proguanil in your blood which may reduce the anti-malarial activity of these medicines. Atovaquone/proguanil should not be taken with efavirenz; your doctor should consider alternatives to these antimalarial medicines.
• Drugs that may interact with JAMP-Efavirenz to affect the electrical activity of your heart which include but may not be limited to macrolide antibiotics (such as clarithromycin) and antimalarials (artemether/lumefantrine).
• Use of EPCLUSA* (sofosbuvir/velpatasvir), VOSEVI* (sofosbuvir/ velpatasvir/voxilaprevir), and MAVIRET* (glecaprevir/pibrentasvir) is not recommended when taking JAMP-Efavirenz.

JAMP-Efavirenz may interact with etonogestrel contraceptive implants. This means your implant might not work and you could get pregnant. You should use a barrier birth control method like a condom. Talk to your healthcare professional for advice on additional birth control methods.

The following medicine should not be taken with JAMP-Efavirenz since it contains efavirenz, the active ingredient in JAMP-Efavirenz:

• ATRIPLA (efavirenz, emtricitabine, tenofovir disoproxil fumarate) unless your doctor decides a dose adjustment is needed (e.g, with rifampin).

• Your doctor may need to adjust the dose of either JAMP-Efavirenz or the following medications when taken with JAMP-Efavirenz:

  • Crixivan* (indinavir)
  • Methadone
  • Zoloft* (sertraline)
  • Wellbutrin SR, Wellbutrin XL, or Zyban (bupropion)
  • Kaletra* (lopinavir/ritonavir) Lopinavir and ritonavir combination should not be taken once daily with JAMP-Efavirenz. Your doctor may suggest an alternate dosing regimen.
  • Celsentri* (maraviroc)
  • Mycobutin* (rifabutin)
  • The cholesterol-lowering medicines Lipitor* (atorvastatin), Pravachol* (pravastatin), andZocor* (simvastatin)
  • Rifadin* (rifampin) or the rifampin- containing medicines Rofact* and Rifater*
  • Calcium channel blockers such as Cardizem* or Tiazac* (diltiazem), Covera HS, Isoptin SR or Tarka (verapamil), and others.
  • Immunosuppressants such as Neoral* (cyclosporin), Advagraf* or Prograf* (tacrolimus), Rapamune* or Torisel* (sirolimus)
  • Hepatitis C antiviral agents such as Victrelis* (boceprevir) and Incivek* (telapravir)
  • Antimalarials such as Coartem*♦ and Riamet*♦ (artemether/lumefantrine)
  • ♦ Not marketed in Canada
  • The effect of combining alcohol or recreational (street, illicit) drugs with JAMP-Efavirenz has not been studied. Because they may interact with each other, speak with your doctor or other healthcare provider before you combine these drugs.

WHILE TAKING JAMP-Efavirenz

Usual Dose

• The dose of JAMP-Efavirenz for adults and children weighing more than 40 kg (88 lbs) is 600 mg once-a-day (one 600 mg tablet).

• You should take JAMP-Efavirenz on an empty stomach, preferably at bedtime. Taking JAMP- Efavirenz with food increases the level of efavirenz in the blood and may increase the possibility of side effects.

• Your doctor or pharmacist will give you instructions for proper dosage

What should I remember to do or avoid while taking JAMP-Efavirenz?

• Swallow JAMP-Efavirenz with water.
• Do not chew the tablets.

PROPER USE OF THIS MEDICATION

• Taking JAMP-Efavirenz at bedtime may improve the tolerability of the nervous system side effects.
• It is important to take JAMP-Efavirenz as your doctor prescribes. Do not change the dose on your own.
• JAMP-Efavirenz should not be used alone to treat HIV. JAMP-Efavirenz should always be taken with other anti-HIV medications in order to prevent the virus from becoming resistant to your drug treatment.
• You should not stop taking JAMP-Efavirenz without first consulting with your doctor.
• If you are unsure of what to do or need help in planning the best times to take your medications, ask your doctor or other healthcare provider.
• If you think it would be useful, ask a friend or family member to remind you to take your medications.
• When your JAMP-Efavirenz supply starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if JAMP-Efavirenz is stopped for even a short time. The virus may then become harder to treat.
• Remember, JAMP-Efavirenz has been prescribed just for you. Never give your medications to others to try.
• Do not use your current supply of JAMP- Efavirenz after the end of the month and year shown by the “expiry date” on the bottle.

Overdose:

Missed Dose:

• If you forget to take JAMP-Efavirenz, do not double your next dose. Take the missed dose as soon as possible, and then carry on with your regular dosing schedule.
• Try not to miss a dose. With anti-HIV medications, missing doses or not taking them properly may allow the amount of HIV in your body to increase. HIV may then become resistant. This means that the virus changes or mutates causing a medication to lose its effect.

• JAMP-Efavirenz, like all medications, affects different people in different ways. Any medication may have unintended or unwanted effects, so-called

  • side effects. Some people may develop side effects, others may not.
  • The most notable side effects of JAMP-Efavirenz are rash and nervous system symptoms that include dizziness, insomnia (difficulty falling asleep), drowsiness, reduced ability to concentrate, and abnormal dreaming. These side effects are generally mild to moderate and tend to disappear after you have taken JAMP-Efavirenz for a few weeks. Decreasing the dose does not seem to help and is not recommended.
  • Some of these side effects such as dizziness will likely be less noticeable if you take JAMP- Efavirenz before going to bed. Be sure to tell your doctor if any of these side effects continue or if they bother you.
  • A small number of patients have had severe depression, strange thoughts, or angry behavior. Some patients have had thoughts of suicide and a few patients have actually committed suicide. These problems tend to occur more often in patients with a history of mental illness. You should contact your doctor immediately if you think you are having these symptoms, so your doctor can decide whether you should continue to take JAMP-Efavirenz.
  • Dizziness, trouble concentrating, and drowsiness have been reported with efavirenz. If you notice any of these symptoms you should avoid potentially hazardous tasks such as driving or operating machinery.
  • You should consult your doctor if you have a rash since some rashes may be serious. However, most cases of rash disappear without any change in your treatment.
  • Rash seems to be more common in children than in adults treated with efavirenz.
  • Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
  • Some patients taking efavirenz have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as a hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
  • Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your

If you think you have taken too much JAMP-Efavirenz, contact a healthcare practitioner (e.g. doctor), hospital emergency department or regional poison control centre, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Grave's disease (which affects the thyroid gland), Guillain-Barre syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor straight away.

Other side effects

• Other common side effects that have been reported include tiredness, nausea, diarrhea and headache.These may be from efavirenz or from other medications that you are taking.
• Tell your doctor or other healthcare provider if you notice these or any other side effects not mentioned in the pamphlet that continue or if they bother you.

Remember do not stop taking JAMP-Efavirenz without speaking to your doctor first. He or she may be able to help you manage these side effects without stopping your anti-HIV medications.

This is not a complete list of side effects. If you have any unexpected effects while taking JAMP-Efavirenz, contact your doctor or pharmacist.

HOW TO STORE IT

JAMP-Efavirenz should be stored in well closed container at controlled room temperature (15 to 30°C).

As with all medications, JAMP-Efavirenz should be kept out of the reach and sight of children.

REPORTING SIDE EFFECTS

If you want more information about JAMP-Efavirenz:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health- products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (www.jamppharma.com) , or by calling at 1-866-399-9091.

JAMP Pharma Corporation

1310 rue Nobel,

Boucherville, Québec,

J4B 5H3

Last revised: June 19, 2020

*Other brands listed are trademarks of their respective owners.

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