Details for: CELSENTRI
Company: VIIV HEALTHCARE ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02299844 | CELSENTRI | MARAVIROC | 150 MG | TABLET | ORAL |
| 02299852 | CELSENTRI | MARAVIROC | 300 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
CELSENTRI is an oral
tablet used for the treatment of HIV-1 (Human
Immunodeficiency Virus type 1) infection in adults, in
combination with other anti-HIV drugs. HIV is the virus
that causes AIDS (Acquired Immune Deficiency
Syndrome). CELSENTRI is a type of anti-HIV drug called
a CCR5 antagonist.
CELSENTRI can reduce the amount of HIV in the blood
(called “viral load”) and increase the number of CD4 (T)
cells. This may keep your immune system healthy, so it
can help fight infection.
CELSENTRI is used with other anti-HIV medicines in
adults with CCR5-tropic HIV-1 infection.
CELSENTRI does not cure HIV infection or AIDS. People
taking CELSENTRI may still develop infections or other
conditions associated with HIV infection. Although
CELSENTRI is not a cure for HIV or AIDS, CELSENTRI
can help reduce your risks of getting illnesses associated
with HIV infection (AIDS and opportunistic infection).
CELSENTRI does not lower your chance of passing HIV
to other people through sexual contact, sharing needles, or
being exposed to your blood. For your health and the
health of others, it is important to always practice safer sex
by using a latex or polyurethane condom or other barrier
method to lower the chance of contact with any body fluids
such as semen, vaginal secretions, or blood. Never re-use
or share needles.
This medicine is prescribed for your particular condition.
Do not use it for any other condition. Do not give
CELSENTRI to other people, even if they have the same
symptoms you have. It may harm them.
What it does
CELSENTRI works by blocking a receptor called CCR5 that a type of HIV uses to enter cells in your blood called CD4 or T-cells. This virus type is called CCR5- tropic HIV. Your doctor may take blood samples to determine if you have been infected with CCR5-tropic HIV and determine if CELSENTRI is an appropriate treatment for you.
When it should not be used
If you are allergic (hypersensitive) to maraviroc or any of the other ingredients of CELSENTRI (see What the important nonmedicinal ingredients are).
CELSENTRI is not recommended for use in children.
What the medicinal ingredient is
The active ingredient is maraviroc.
What the non-medicinal ingredients are
Other
non-medicinal ingredients present in CELSENTRI film-coated
tablets include: microcrystalline cellulose, dibasic calcium
phosphate, sodium starch glycolate, magnesium stearate.
Film-coat: aluminum lake (FD&C blue #2), macrogol 3350,
polyvinyl alcohol, soya lecithin, talc, and titanium dioxide.
What dosage form it comes in
CELSENTRI comes in oval-shaped, blue, film-coated tablets in 150 mg and 300 mg strengths.
Warnings and precautions
Serious Warnings and Precautions
Liver problems
Liver problems (liver toxicity) have happened in
patients taking CELSENTRI. An allergic reaction may
happen before liver problems occur. Stop taking
CELSENTRI and call your doctor right away if you get any
of the following symptoms:
- an itchy rash on your body (allergic reaction)
- your skin or eyes look yellow and/or dark (tea-colored) urine
- vomiting and/or upper right stomach area (abdominal) pain
You should see your doctor right away but continue taking CELSENTRI if you have any of the following other symptoms: nausea, fever, flu-like symptoms, fatigue.
BEFORE you use CELSENTRI talk to your doctor or pharmacist if:
- You have liver problems or are infected with Hepatitis B and/or Hepatitis C, as your liver function may need to be closely monitored.
- You have a history of low blood pressure or low blood pressure on standing (postural hypotension) and/or if you are taking any medication to lower blood pressure.
- You have heart disease
- You have a history of any kidney problems.
- You are pregnant, planning to become pregnant, or become pregnant while taking CELSENTRI. It is not known if CELSENTRI can harm your unborn child. You and your doctor will need to decide if taking CELSENTRI is right for you. If you take CELSENTRI while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
- You are breast-feeding. You should not breast-feed if you are HIV-positive because of the chance of passing HIV to your baby. Also, it is not known if CELSENTRI can pass into your breast milk and if it can harm your baby. Talk with your doctor about the best way to feed your baby.
Other warnings:
- It is very important to take all your anti-HIV medicines as prescribed and at the right times of day. This can help your medicines work better. It also lowers the chance that your medicines will stop working to fight HIV (drug resistance).
- When your CELSENTRI supply starts to run low, ask your doctor or pharmacist for a refill. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short period of time.
- You should never stop taking CELSENTRI or your other HIV medicines without talking with your doctor.
- Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking CELSENTRI. These reactions included rash, fever and sometimes organ dysfunction and liver failure. If you get any of the following symptoms while you’re taking CELSENTRI:
- Swelling of the face, lips or tongue
- Difficulty breathing
- Widespread skin rash
- Blisters and peeling skin, particularly around the mouth, nose, eyes and genitals
- Symptoms of liver problems such as a general feeling of being sick or unwell, feeling very tired, loss of appetite, stomach pain, itching, yellowing of the skin and eyes, dark urine, drowsiness and confusion.
Contact a doctor immediately. Stop taking CELSENTRI.
Interactions with this medication
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your doctor may need to adjust your dose of CELSENTRI depending on which other medications you are taking. Do not start or stop any other medications without your doctor or pharmacist’s approval. The following medications are known to interact or may interact with CELSENTRI and your doctor may adjust the dosage of CELSENTRI:
- clarithromycin, ketoconazole, itraconazole, rifampin
- delavirdine
- atazanavir, atazanavir/ritonavir, darunavir/ritonavir, efavirenz, etravirine, lopinavir/ritonavir, saquinavir, saquinavir/ritonavir, nelfinavir, fosamprenavir/ritonavir and other anti-HIV combinations
- anticonvulsant medicines (carbamazepine, phenobarbital, phenytoin)
- St. John's Wort (Hypericum perforatum) should not be used as it may reduce the amount of CELSENTRI in the blood and reduce the effectiveness of this medication.
Tell your doctor if you are taking fluconazole.
Proper use of this medication
Usual adult dose:
CELSENTRI should be taken every day as prescribed in combination with other medicines used to treat HIV. The recommended dose of CELSENTRI in adults is 300 mg twice daily. However, a dose adjustment may be needed due to the potential for interactions with other medicinal products. Further adjustment may be necessary if you also have kidney problems. CELSENTRI can be taken with or without food. CELSENTRI comes in a tablet form and should be swallowed with plenty of liquid (e.g. water). Do not chew the tablets.
Overdose
Missed Dose
If you forget to take CELSENTRI, take the next dose of CELSENTRI as soon as possible and then take your next scheduled dose at its regular time. If, however, it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
Side effects and what to do about them
Like all medicines, CELSENTRI can cause side effects,
although not everybody gets them.
The most common side effects include: cough, fever, upper
respiratory tract infections, rash, muscle-related symptoms
(such as muscle pain, aches or soreness), abdominal pain,
dizziness, constipation, itching, difficulty sleeping,
diarrhea, nausea, and headache.
Tell your doctor promptly about these or other symptoms.
If the condition persists or worsens, seek medical attention.
Changes to your immune system (Immune Reconstitution
Inflammatory Syndrome) can happen when you start taking
HIV-1 medicines. Your immune system may get stronger
and begin to fight infections that have been hidden in your
body for a long time.
Autoimmune disorders (when the immune system attacks
healthy body tissue), may also occur after you start taking
medicines for HIV infection. Examples of this include:
Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system),
polymyositis (which affects the muscles), or autoimmune
hepatitis (which affects the liver). Autoimmune disorders
may occur many months after the start of treatment. Look
for any other symptoms such as:
- High temperature (fever), redness, rash or swelling
- Fatigue
- Joint or muscle pain
- Numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body
- Palpitations (chest pain) or rapid heart rate
- Yellowing of the skin or eyes
If you notice these or any symptoms of inflammation or
infection, tell your doctor immediately.
If you experience dizziness or fainting while taking
CELSENTRI, do not drive or operate heavy machinery.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Possible chance of infection | ✔ | ||
| Breathing abnormalities | ✔ | ||
| Uncommon | |||
| Heart problems including heart attack | ✔ | ||
| Immune Reconstitution Inflammatory Syndrome (your immune system may get stronger and could begin to fight other infections) | ✔ | ||
| Low blood pressure when standing up (postural hypotension) can cause dizziness or fainting | ✔ | ||
| Rare | |||
| A severe or lifethreatening skin reaction (see WARNINGS AND PRECAUTIONS) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking CELSENTRI, contact your doctor or pharmacist.
How to store
Store between 15°C and 30°C, in the original package. Do not take CELSENTRI after the expiry date shown on the package. Keep out of the reach of children. This medicine has been prescribed for your medical problem. Do not give it to anyone else. Discuss all your questions about your health with your doctor. If you have questions about CELSENTRI ask your doctor, nurse or pharmacist.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared
for health professionals can be found at:
www.viivhealthcare.com
or by contacting the sponsor, ViiV Healthcare ULC at:
245, boulevard Armand-Frappier
Laval, Quebec
H7V 4A7
1-877-393-8448
This leaflet was prepared by ViiV Healthcare ULC.
Last revised: July 5, 2019
© 2019 ViiV Healthcare group of companies or its licensor.
Trademarks are owned by or licensed to the ViiV Healthcare
group of companies.