Patient Medication Information: uses, side effects, how to take - Vemlidy
Serious Warnings and Precautions
- “Flare-ups” of Hepatitis B Virus infection can occur if you stop taking Vemlidy. In these cases, your infection may return and become worse than it was before. Do not stop taking Vemlidy without your doctor’s advice. If you stop taking Vemlidy, tell your doctor right away. Tell your doctor about any unusual or worsening symptoms that you notice after stopping treatment. After you stop taking Vemlidy, your doctor will still need to check your health and take blood tests regularly for several months to check your HBV infection.
What is Vemlidy used for?
Vemlidy is used to treat chronic (long-lasting) hepatitis B in adults. Hepatitis B is caused by an infection with the hepatitis B virus (HBV).
How does Vemlidy work?
Vemlidy blocks the virus from making more copies of itself in the body. This may help lower the amount of HBV in your body and reduce the infection.
What are the ingredients in Vemlidy?
Each tablet has the following medicines: tenofovir alafenamide*
(*as tenofovir alafenamide hemifumarate)
Each tablet has the following ingredients that are not medicines: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
Each tablet is covered with the following ingredients that are not medicines: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Vemlidy comes in the following dosage forms:
Vemlidy comes in yellow tablets. Each tablet has 25 mg of tenofovir alafenamide (equal to 28.0 mg of tenofovir alafenamide hemifumarate).
Do not use Vemlidy if you:
- have an allergy to tenofovir alafenamide or any of the other ingredients in this product (Read also “What are the ingredients in Vemlidy?” above).
To help avoid side effects, make sure you take your medicine correctly. Talk to your doctor before you take Vemlidy. Talk about any health problems you may have, including if you:
are taking any medicine that is listed under “Drugs that should not be taken with
Vemlidy”.
have any other health problems, including Human Immunodeficiency Virus (HIV) infection.
Your doctor may test you for HIV before starting Vemlidy. If you have HIV and take Vemlidy, your HIV may become harder to treat.
have severe liver problems (hepatotoxicity) with an enlarged (hepatomegaly) and fatty liver
(steatosis).
- have kidney problems. Kidney problems, including kidney failure, have occurred in patients taking tenofovir. If you have kidney problems and are taking Vemlidy along with certain medicines such as non-steroidal anti-inflammatory drugs, your kidney problems could get worse.
- have lactic acid in the blood (lactic acidosis).
Other warnings you should know about:
If you are pregnant or plan to become pregnant:
It is not known if Vemlidy can harm your unborn child. Your doctor will decide if you should take Vemlidy.
Pregnancy Registry: There is a pregnancy registry for women who take medicines such as Vemlidy during pregnancy. This registry collects information about your health and your baby’s health. If you become pregnant while taking Vemlidy, talk with your doctor about taking part in this Pregnancy Registry.
If you are breast-feeding or plan to breast-feed:
If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.
Tell your doctor about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Do not start a new medicine without telling your doctor. Your doctor can tell you if it is safe to take Vemlidy with other medicines.
Drugs that should not be taken with Vemlidy:
Any other medicines that contain tenofovir alafenamide (GENVOYA®, DESCOVY®,
ODEFSEY®, BIKTARVY®, Symtuza®).
Any other medicines that contain tenofovir disoproxil fumarate (ATRIPLA®,
COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®).
- Adefovir (HEPSERA®).
The following may interact with Vemlidy:
Antimycobacterials such as rifabutin (Mycobutin®), rifampin (Rifadin®,
Rifamate®*, Rifater®*, Rofact®), and rifapentine (*Not available in Canada).
- Herbal products such as Hypericum perforatum (St. John’s wort).
How to take Vemlidy:
- Stay under a doctor’s care when taking Vemlidy.
- Do not change your dose or stop taking Vemlidy without first talking with your doctor.
When your Vemlidy supply starts to run low, get more from your doctor or
pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. If Vemlidy is not taken on a regular basis, the virus may become harder to treat.
Usual adult dose:
Take one tablet (by mouth) once each day with or without food. Try to take the tablet at the same time each day. Swallow with plenty of water.
Overdose:
If you think you have taken too much Vemlidy, contact your doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
It is important to take Vemlidy each day.
- If you miss a dose of Vemlidy and you notice within 18 hours, take a tablet as soon as you can. Then take the next dose at your usual time.
- If you miss a dose of Vemlidy and you notice after 18 hours, wait and take the next dose at your usual time. Do NOT take a double dose (two doses close together).
What to do if you vomit (throw up):
- If you vomit less than 1 hour after taking Vemlidy, take another tablet.
- If you vomit more than 1 hour after taking Vemlidy, wait. DO NOT take another tablet until you are scheduled to take the next tablet.
Call your doctor or pharmacist if you are not sure what to do.
What are possible side effects from using Vemlidy?
These are not all the possible side effects you may feel when taking Vemlidy. If you
experience any side effects not listed here, contact your healthcare professional.
- The most common side effect of Vemlidy is nausea.
- Other side effects include headache, abdominal pain, feeling tired, diarrhea, vomiting, rash, flatulence, swelling of the face, lips, tongue or throat (angioedema), and hives (urticaria).
- Please also see “Serious side effects and what to do about them” table, below.
Serious side effects and what to do about them
| Symptoms / effect | Talk to your doctor | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
RARE Lactic acidosis (acid in the blood), with symptoms such as:
|
✓ ✓
| ||
VERY RARE Flare-ups of hepatitis B virus infection following drug discontinuation, with symptoms such as:
| ✓
✓ ✓ ✓ | ||
Serious side effects and what to do about them
| Symptoms / effect | Talk to your doctor | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
VERY RARE Hepatotoxicity (severe liver problems) with hepatomegaly (liver enlargement) and steatosis (fat in the liver), with symptoms such as:
| ✓ ✓ ✓ ✓ ✓ ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your doctor.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html)
for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your doctor if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store Vemlidy below 30°C (86°F).
- Keep Vemlidy in its original container and keep the container tightly closed.
- Do not use Vemlidy if the seal over the bottle opening is broken or missing.
- Keep this medicine where children cannot reach it or see it.
If you want more information about Vemlidy:
- Talk to your doctor.
Find the full product monograph that is prepared for doctors and includes this Patient
Medication Information by visiting the Health Canada website
(https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.gilead.ca, or by calling 1-866-207-4267.
Last Revised: August 20, 2020
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
ATRIPLA®, BIKTARVY®, VEMLIDY®, ODEFSEY®, DESCOVY®, GENVOYA®, STRIBILD®, COMPLERA®, TRUVADA®, VIREAD® and HEPSERA® are trademarks of Gilead Sciences, Inc. or its related companies.
Other brands listed are trademarks of their respective owners.
© 2020 Gilead Sciences, Inc. All rights reserved.
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