Patient Medication Information: uses, side effects, how to take - Celsentri
What is CELSENTRI used for?
CELSENTRI is used for the treatment of HIV-1 (Human Immunodeficiency Virus type 1) infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
CELSENTRI is a type of anti-HIV medicine called a CCR5 antagonist. CELSENTRI is used in combination with other anti-HIV medicine.
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).
This medicine is prescribed for your 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.
Your healthcare professional 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.
Serious Warnings and Precautions
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 healthcare professional right away if you get any of the following symptoms:
You should see your healthcare professional right away but continue taking CELSENTRI if you have any of the following other symptoms: nausea, fever, flu-like symptoms, fatigue. |
How does CELSENTRI work?
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 (these are types of white blood cells). This virus type is called “CCR5-tropic HIV.” CELSENTI can lower the amount of HIV in the blood (called “viral load”) and increase the number of CD4(T) cells (a type of white blood cell). This may keep your immune system healthy, so it can help fight infection.
What are the ingredients in CELSENTRI?
Medicinal ingredients: maraviroc.
Non-medicinal ingredients: aluminum lake (FD&C blue #2), dibasic calcium phosphate, microcrystalline cellulose, macrogol 3350, magnesium stearate, polyvinyl alcohol, sodium starch glycolate, soya lecithin, talc, titanium dioxide.
CELSENTRI comes in the following dosage forms:
Film-coated tablets: 150 mg, 300 mg
Do not use CELSENTRI if:
If you are allergic (hypersensitive) to maraviroc or any of the other ingredients of CELSENTRI (see What are the ingredients in CELSENTRI?).
CELSENTRI is not recommended for use in children.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CELSENTRI. Talk about any health conditions or problems you may have, including 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
- have a history of low blood pressure or low blood pressure when standing (postural hypotension)
- are taking any medication to lower blood pressure
- have heart disease
- have a history of any kidney problems
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 healthcare professional will need to decide if taking CELSENTRI is right for you
- If you take CELSENTRI while you are pregnant, talk to your healthcare professional about how you can be included in the Antiretroviral Pregnancy Registry
are breast-feeding. Women who are HIV positive should not breastfeed because the HIV infection can pass into the breastmilk
- It is not known if CELSENTRI can pass into your breast milk and if it can harm your baby. Talk to your healthcare professional about the best way to feed your baby
Other warnings you should know about:
Severe Allergic Reactions:
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.
Stop taking CELSENTRI and talk to your healthcare professional right away if you get any of the following symptoms while you are 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
Immune System Changes:
Changes to your immune system called 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, which is 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)
- Autoimmune hepatitis (which affects the liver)
Autoimmune disorders may occur many months after the start of treatment.
See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.
Check-ups and testing:
your healthcare professional may closely monitor your liver function if you have a history of liver problems including hepatitis B or C.
Driving and Using Machines:
If you become drowsy, dizzy or light-headed while taking CELSENTRI, do not drive or operate heavy machinery.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with CELSENTRI:
- Medicines used to treat bacterial infections (antibiotics) like clarithromycin, ketoconazole, itraconazole, rifampin
- Delavirdine, used to treat HIV
- Medicines used to treat HIV and AIDS (antiretroviral) like atazanavir, atazanavir/ritonavir, darunavir/ritonavir, efavirenz, etravirine, lopinavir/ritonavir, saquinavir, saquinavir/ritonavir, nelfinavir, fosamprenavir/ritonavir and other anti-HIV combinations
- Medicines used to treat seizures or convulsions (anticonvulsants) like carbamazepine, phenobarbital, and phenytoin
St. John's Wort (Hypericum perforatum), a herbal remedy to treat depression
- It should not be used as it may lower the amount of CELSENTRI in the blood and make it not treat your condition as well.
- Fluconazole, used to treat fungal infections
How to take CELSENTRI:
Usual dose:
Take CELSENTRI exactly as your healthcare professional has told you. CELSENTRI should be taken every day with other medicines used to treat HIV.
The recommended dose of CELSENTRI in adults is 300 mg two times a day.
Your healthcare professional may need to change the amount of CELSENTRI you take depending on what other medicines you are taking. The amount of CELSENTRI you take may also be changed if you have kidney problems. Do not start or stop any other medicines without talking to your healthcare professional first.
CELSENTRI can be taken with or without food. CELSENTRI tablets should be swallowed with plenty of water. Do not chew the tablets.
To control your HIV infection and to stop your illness from getting worse, you must keep taking all your medicines, unless your healthcare professional tells you otherwise.
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).
Be sure to keep a supply of your anti-HIV medicines. When your CELSENTRI supply starts to run low, get more from your healthcare professional or pharmacy. Do not wait until your medicine runs out to get more. 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 to your healthcare professional.
Overdose:
| If you think you, or a person you are caring for, have taken too much CELSENTRI, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you forget to take CELSENTRI, take the next dose of CELSENTRI as soon as possible. Take your next dose at its usual time.
If 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 two doses to make up for a missed dose.
What are possible side effects from using CELSENTRI?
These are not all the possible side effects you may have when taking CELSENTRI. If you experience any side effects not listed here, tell your healthcare professional.
- 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
- headache
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| COMMON | |||||
Possible chance of infection: fever, generally ill feeling | √ | ||||
Breathing abnormalities: trouble breathing | √ | ||||
| UNCOMMON | |||||
| Heart problems: including heart attack, chest pain | √ | ||||
| Immune Reconstitution Inflammatory Syndrome: fever, | √ | ||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| redness, rash or swelling, fatigue, joint or muscle pain, numbness, tingling, or weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, chest pain or rapid heartbeat, yellowing of the skin or eyes, anxiety and irritability accompanied by tremor of your hands or fingers, muscle weakness in your hips, thighs, shoulders, upper arms and neck, difficulty breathing, fainting | |||||
| Postural Hypotension (low blood pressure when standing up): can cause dizziness or fainting | √ | ||||
| RARE | |||||
| Severe or life-threatening skin reactions severe rash, blistering or peeling skin, general ill feeling, extreme tiredness, muscle or joint aches, fever, blisters or sores in your mouth, redness or swelling of the eyes, swelling of your face, lips, mouth, tongue or throat, trouble breathing or swallowing | √ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store between 15°C to 30°C, in the original package.
Do not take CELSENTRI after the expiry date shown on the package.
Keep out of reach and sight of children.
If you want more information about CELSENTRI:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.viivhealthcare.ca, or by calling 1-877-393-8448.
Last Revised JULY 12, 2023
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