Celsentri

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Celsentri. If you are concerned about side effects, discuss the risks and benefits of Celsentri with your doctor.

The following side effects have been reported by at least 1% of people taking Celsentri. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Constipation
• cough
• Diarrhea
• difficulty sleeping
• dizziness, especially when standing from a sitting or lying down position
• headache
• itching
• muscle aches and pains
• nausea
• upper respiratory tract infection (e.g., runny nose, sore throat)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• herpes infection (mouth or genital sores or blisters)
• signs of infection (e.g., Fever, chills, sore throat, mouth ulcers, cough)
• signs of liver problems (e.g., itchy rash, yellowing of the eyes or skin, dark urine, vomiting, upper right abdominal pain)
• trouble breathing
• unexplained muscle aches, soreness, or pain

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a Heart Attack (e.g., chest pain, tightness or pressure, nausea, vomiting, sweating, sense of impending doom)
• signs of a Anaphylaxis (severe allergic reaction) (e.g., Hives; skin rash; itchy skin; trouble breathing; or swelling of the face, lips, tongue, or throat)
• signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Celsentri.

150 mg
Each blue, biconvex, oval, film-coated tablet, debossed with "Pfizer" on one side and "MVC 150" on the other, contains maraviroc 150 mg. Nonmedicinal ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate; film-coating: opadry II blue, FD&C Blue No. 2 Aluminum Lake, polyethylene glycol (macrogol 3350), polyvinyl alcohol, soya lecithin, talc, and titanium dioxide.

300 mg
Each blue, biconvex, oval, film-coated tablet, debossed with "Pfizer" on one side and "MVC 300" on the other, contains maraviroc 300 mg. Nonmedicinal ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate; film-coating: opadry II blue, FD&C Blue No. 2 Aluminum Lake, polyethylene glycol (macrogol 3350), polyvinyl alcohol, soya lecithin, talc, and titanium dioxide.

Do not take maraviroc if you are allergic to maraviroc or to any of the ingredients of the medication.

There may be an interaction between maraviroc and any of the following:

• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Cobicistat
• conivaptan
• Deferasirox
• Dronedarone
• Enzalutamide
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV nucleoside reverse transcriptase inhibitors (NRTIs; e.g., abacavir, didanosine, lamivudine, tenofovir, zidovudine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• lumacaftor
• nefazodone
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Metronidazole
• mifepristone
• Mitotane
• Modafinil
• nefazodone
• Orlistat
• Phenobarbital
• Phenytoin
• primidone
• rifampin
• St. John's wort
• siltuximab
• simeprevir
• Stiripentol
• Tocilizumab
• certain tyrosine kinase inhibitors (e.g., Ceritinib, Crizotinib, Dabrafenib, Dasatinib, imatinib)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Celsentri. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Celsentri.

Blood pressure: Maraviroc may cause dizziness and a drop in blood pressure when rising from a sitting or lying down position, especially if you are taking medications that lower blood pressure. Get up slowly from a sitting or lying down position while you are taking Celsentri. If you faint while taking Celsentri, contact your doctor.

Dizziness: If you experience dizziness while taking maraviroc, do not drive or operate heavy machinery until you are no longer experiencing this side effect.

Heart disease: Maraviroc may increase the risk of heart attack or chest pain, particularly for people who have a history of heart problems. If you have a history of heart disease or are at risk for heart disease, discuss with your doctor how Celsentri may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Celsentri, and whether any special monitoring is needed.

Hepatitis B or C: If you have hepatitis B or C, discuss with your doctor how Celsentri may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Celsentri, and whether any special monitoring is needed.

If you experience symptoms of liver problems (itchy rash, yellowing of the eyes or skin, dark urine, vomiting, upper right abdominal pain), stop taking maraviroc and contact your doctor immediately. Continue taking maraviroc and see your doctor immediately if you experience nausea, fever, flu-like symptoms, or fatigue.

Hypersensitivity reactions: A severe allergic reaction called hypersensitivity syndrome has occurred for some people with the use of maraviroc. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Immune reconstitution inflammatory syndrome: A condition called immune reconstitution inflammatory syndrome can occur when you start taking HIV medications such as maraviroc. Your immune system may get stronger and start to fight other infections that have been hidden in your body (e.g., pneumonia, herpes, or Tuberculosis). Contact your doctor if you develop any new symptoms after starting HIV medications such as maraviroc.

Infections: People taking maraviroc can experience an increase in infections, most commonly, upper respiratory tract infections. If you experience increased symptoms such as cough, sinus congestion, or sore throat, speak with your doctor.

Kidney function: The safety and effectiveness of maraviroc have not been established for people with reduced kidney function. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Celsentri may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Celsentri, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause maraviroc to build up in the body, causing side effects. Maraviroc may also cause liver failure or a decrease in liver function. If you experience symptoms of liver problems (itchy rash, yellowing of the eyes or skin, dark urine, vomiting, upper right abdominal pain), stop taking maraviroc and contact your doctor immediately. Continue taking maraviroc and see your doctor immediately if you experience nausea, fever, flu-like symptoms, or fatigue.

If you have reduced liver function or liver disease, discuss with your doctor how Celsentri may affect your medical condition. Your doctor will monitor your liver function closely while you are taking Celsentri.

Pregnancy: Celsentri should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Celsentri, contact your doctor immediately.

Breast-feeding: It is not known if maraviroc passes into breast milk. However, breast-feeding is not recommended for HIV-positive women since the virus can be passed through breast-milk.

Children: The safety and effectiveness of using Celsentri have not been established for children less than 18 years of age.