Celsentri 300 mg film-coated tablets – patient leaflet, side effects, dosage

1. What CELSENTRI is and what it is used for

CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of medicines called CCR5 antagonists. CELSENTRI works by blocking a receptor called CCR5 which HIV uses to enter and infect your blood cells.

CELSENTRI is used to treat Human

Immunodeficiency Virus type-1 (HIV-1) in adults and adolescents weighing at least 30 kg.

CELSENTRI must be taken in combination with other medicines which are also used to treat the HIV infection. These medicines are all called anti-HIV medicines or antiretrovirals.

CELSENTRI, as part of combination therapy, reduces the amount of virus in your body, and keeps it at a low level. This helps your body to increase the CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body to fight infection.

2. What you need to know before you take CELSENTRI

Do not take CELSENTRI

• if you are allergic to maraviroc or to peanut or

  soya or to any of the other ingredients of CELSENTRI (listed in section 6).

➔ Check with your doctor if you think this applies

to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking or giving CELSENTRI.

Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for you.

Some people taking CELSENTRI have developed serious allergic reactions or skin reactions (see also ‘Serious side effects’ in section 4).

Before taking this medicine, make sure that your doctor knows if you have or in the past had any of the following:

• liver problems, including chronic hepatitis B or

  C. Only a limited number of people with liver problems have taken CELSENTRI. Your liver function may need to be closely monitored. (See also ‘Liver problems’ in section 4).

• low blood pressure, including dizziness when

  you stand up or sit up quickly, or if you are taking any medicines to lower blood pressure. This is due to a sudden fall in blood pressure. If this

  happens, lie down until you feel better. When getting up, do so as slowly as possible.

• tuberculosis (TB) or serious fungal infections.

  CELSENTRI could potentially increase your risk of developing infections.

• kidney problems. This is particularly

  important if you are also taking some other medicines (see ‘Other medicines and CELSENTRI’ later in section 2).

• problems with your heart or circulatory

  system. Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI.

➔ Tell your doctor before starting treatment if you

think any of these apply to you.

Conditions you need to look out for

Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

• symptoms of infections and inflammation

• joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you’re taking CELSENTRI. ➔ Read the information ‘Other possible side

  effects of combination therapy for HIV’ in Section 4 of this leaflet.

Older people

CELSENTRI has only been taken by limited numbers of people 65 years or older. If you belong to this age group, discuss with your doctor if you can use CELSENTRI.

Children

The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg. Therefore CELSENTRI is not recommended in children younger than 2, or weighing less than 10 kg.

Other medicines and CELSENTRI

Tell your doctor or pharmacist if you are taking, any other medicines, have recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you begin taking a new medicine while taking CELSENTRI. Medicines containing St. John’s Wort (Hypericum perforatum) are likely to prevent CELSENTRI from working properly. You should not take them while you’re taking CELSENTRI.

Some medicines may change the amount of CELSENTRI in the body when they are taken at the same time as CELSENTRI. These include:

• other medicines to treat HIV or hepatitis C infection (such as atazanavir, cobicistat, darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
• antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)

• antifungal medicines (ketoconazole,

  itraconazole, fluconazole)

• anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).

➔ Tell your doctor if you are taking any of these medicines. This will allow your doctor to prescribe the right dose of CELSENTRI. Pregnancy and breast-feeding

If you are pregnant, if you become pregnant, or if you are planning to have a baby:

➔ Talk to your doctor about the risks and benefits of taking CELSENTRI.

Breast-feeding is not recommended in women living with HIV, because HIV infection can be passed on to the baby in breast milk.

It is not known whether the ingredients in CELSENTRI can also pass into breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines

CELSENTRI can make you dizzy.

➔ Do not drive, cycle, or operate tools or machines unless you are sure you’re not affected. CELSENTRI contains soya lecithin and sodium.

If you are allergic to peanut or soya do not use this medicinal product.

CELSENTRI contains less than 1 mmol sodium (23 mg) in each tablet, that is to say essentially ‘sodium free’.

3. How to take CELSENTRI

Always take or give this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will advise you whether it is better to take CELSENTRI oral solution, if you are unable to swallow tablets.

How much to take

Adults

The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice per day depending on other medicines that you are taking at the same time. Always take the dose recommended by your doctor.

People with kidney problems

If you have a kidney problem, your doctor may alter your dose.

➔ Talk to your doctor if this applies to you. CELSENTRI can be taken with or without food. CELSENTRI should always be taken by mouth. CELSENTRI must be taken in combination with other medicines to treat HIV. Refer to the Package Leaflets of these other medicines for guidance on how to take them.

If you take or give more CELSENTRI than you should

If you accidentally take or give too much CELSENTRI:

➔ Contact your doctor or the nearest hospital immediately.

If you forget to take or give CELSENTRI

If you miss a dose of CELSENTRI, take or give the missed dose as soon as possible and then continue with the next dose at its regular time.

If it is almost time for the next dose, do not take or give the missed dose. Wait for the next dose at its regular time.

Do not take or give a double dose to make up for a forgotten dose.

If you stop taking CELSENTRI

Keep taking CELSENTRI until your doctor tells you to stop.

Taking your medicines at the right time every day is important, as it makes sure the HIV infection does not increase in your body. Therefore, unless your doctor tells you to stop treatment, it is important to keep taking CELSENTRI correctly, as described above.

If you have any further questions on the use of this medicine, ask your doctor or your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice anything unusual about your own health.

Serious side effects — get medical help immediately

Serious allergic or skin reactions

Some people taking CELSENTRI have developed severe and life-threatening skin reactions and allergic reactions. These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI. If you get any of the following symptoms while you’re taking CELSENTRI :

• swelling of the face, lips or tongue
• difficulty breathing

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• widespread skin rash
• fever (high temperature)

• blisters and peeling skin, particularly around the

  mouth, nose, eyes and genitals.

➔ Get medical help immediately if you get these

symptoms. Stop taking CELSENTRI. Liver problems

These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.

Signs include:

• loss of appetite
• feeling sick or being sick
• yellowing of skin or eyes
• skin rash or itching
• feeling very tired
• stomach pain or tenderness
• dark urine
• drowsiness and confusion
• fever (high temperature).

➔ Contact a doctor immediately if you get these

symptoms. Stop taking CELSENTRI. Other side effects

Common side effects

These may affect 1 to 10 in 100 people:

• diarrhoea, feeling sick, stomach ache, wind

  (flatulence),

• loss of appetite
• headache, problems sleeping, depression

• rash (see also ‘Serious allergic or skin reactions’

  earlier in section 4)

• feeling weak or lack of energy, anaemia (seen in

  blood test result)

• increase in liver enzymes (seen in blood test

  results), which can be a sign of liver problems (see also ‘Liver problems’ earlier in section 4). Uncommon side effects

These may affect up to 1 in 100 people:

• lung infection
• fungal infection of the gullet (oesophagus)
• fits (seizures)

• feeling dizzy, faint or light headed when standing

  up

• kidney failure, protein in the urine

• an increase in a substance known as CPK (seen

  in blood test results) which is a sign that muscles are inflamed or damaged.

Rare side effects

These may affect up to 1 in 1,000 people:

• chest pain (caused by reduced blood flow to the

  heart)

• decrease in muscle size

• some types of cancer, such as of the gullet

  (oesophagus) and bile duct

• decrease in number of blood cells (seen in blood

  test results).

Other possible side effects of combination therapy for HIV

People taking combination therapy for HIV may get other side effects.

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When they start treatment, the immune system becomes stronger, so the body starts to fight infections.

Symptoms of infection and inflammation may develop, caused by either:

• old, hidden infections flaring up again as the

  body fights them

• the immune system attacking healthy body tissue

  (autoimmune disorders).

The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:

• muscle weakness

• weakness beginning in the hands and feet and

  moving up towards the trunk of the body

• palpitations or tremor

• hyperactivity (excessive restlessness and

  movement).

If you get any symptoms of infection or if you notice any of the symptoms above:

➔ Tell your doctor immediately. Don’t take other

medicines for the infection without your doctor’s advice.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone.

It is not known how common this condition is. You may be more likely to develop it:

• if you have been taking combination therapy for a

  long time

• if you are also taking anti-inflammatory medicines

  called corticosteroids

• if you drink alcohol
• if you have a very weak immune system
• if you are overweight.

Signs to look out for include:

• stiffness in the joints

• aches and pains (especially in the hip, knee or

  shoulder)

• difficulty moving.

If you notice any of these symptoms:

➔ Tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CELSENTRI

Keep this medicine out of the sight and reach of children.

Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What CELSENTRI contains

• The active ingredient is maraviroc.

  Each film-coated tablet contains 150 mg or 300 mg of maraviroc.

• The other ingredients are:

  Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate

  Film-coat: poly (vinyl alcohol), titanium dioxide

  (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).

What CELSENTRI looks like and contents of the pack

CELSENTRI film-coated tablets are blue coloured with “MVC 150” or “MVC 300”.

CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 60 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets. Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder

ViiV Healthcare UK Limited, 79 New Oxford Street London, WC1A 1DG, United Kingdom

Manufacturer

Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1,

79108 Freiburg Im Breisgau,

Germany.

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information: Product name: CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets

Reference number: 35728/0036

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in March 2025.

Trade marks are owned by or licensed to the ViiV Healthcare group of companies.

©2025 ViiV Healthcare group of companies or its licensor.

NOTE TO MARKET Local approvers must ensure that trade mark and copyright statements included in the brief

comply with guidance provided by Legal: Global Trade Marks.

IMPORTANT GSK LOC is responsible to

and complete.

pre-press suitability.

GSK Market is responsible to advise SDC when changes required impact the following:

Formulation Tablet embossing Storage conditions

Shelf Life

AIP_Production_V_INDD - 01_2023 - Version 4