Colcrys

Colcrys is a prescription medication used to prevent and treat gout attacks and familial Mediterranean fever (FMF). Colcrys belongs to a group of drugs called antigout agents. It is thought to work by inhibiting the activity of neutrophils (inflammatory cells), which results in the reduction of inflammation and the symptoms of gout.

Colcrys is a prescription medicine used to:

• prevent and treat gout flares in adults
• treat familial Mediterranean fever (FMF) in adults and children age four or older.

• Takeda Pharmaceuticals America, Inc.

Colcrys can cause serious side effects or even cause death. Get medical help right away, if you have:

• Muscle weakness or pain
• Numbness or tingling in your fingers or toes
• Unusual bleeding or bruising
• Increased infections
• Feel weak or tired
• Pale or gray color to your lips, tongue, or palms of your hands
• Severe diarrhea or vomiting

Gout Flares: The most common side effect of Colcrys in people who have gout flares is diarrhea.

FMF: The most common side effects of Colcrys in people who have FMF are abdominal pain, diarrhea, nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Colcrys. For more information, ask your healthcare provider or pharmacist.

Tell your doctor about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics.  Especially tell your doctor if you are taking:

• atazanavir sulfate (Reyataz)
• clarithromycin (Biaxin)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• darunavir (Prezista)
• fosamprenavir (Lexiva) with ritonavir
• fosamprenavir (Lexiva)
• indinavir (Crixivan)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• Iopinavir/ritonavir (Kaletra)
• nefazodone (Serzone)
• nelfinavir mesylate(Viracept)
• ritonavir (Norvir)
• saquinavir mesylate (Invirase)
• telithromycin (Ketek)
• tipranavir (Aptivus)

Do not start a new medicine without talking to your doctor.

Colcrys can cause serious side effects or death if levels of Colcrys are too high in your body.

• Taking certain medicines with Colcrys can cause your level of Colcrys to be too high, especially if you have kidney or liver problems.
• Tell your doctor about all your medical conditions, including if you have kidney or liver problems. Your dose of Colcrys may need to be changed.
• Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
• Even medicines that you take for a short period of time, such as antibiotics, can interact with Colcrys and cause serious side effects or death.
• Talk to your doctor or pharmacist before takng any new medicine.
• See "Drug Interactions"

Do not take Colcrys if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed.

Avoid eating grapefruit or drinking grapefruit juice while taking Colcrys. It can increase your chances of getting serious side effects.

Before you take Colcrys tell your doctor about all your medical conditions including if you:

• have liver or kidney problems
• are pregnant or plan to become pregnant. It is not known if Colcrys will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. Colcrys passes into your breast milk. You and your doctor should decide if you will take Colcrys or breastfeed. If you take Colcrys and breastfeed, you should talk to your child's doctor about how to watch for side effects in your child.

Tell your doctor about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics. Do not start a new medicine without talking to your doctor. Using Colcrys with certain other medicines, such as cholesterol-lowering medications and digoxin, can affect each other causing serious side effects. Your doctor may need to change your dose of Colcrys. Talk to your doctor about whether the medications you are taking might interact with Colcrys, and what side effects to look for.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or if you plan to breastfeed. Colcrys is excreted in human breast milk. It is not known if Colcrys will harm your baby.

• Take Colcrys exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider.
• Colcrys can be taken with or without food.
• If you take too much Colcrys go to the nearest hospital emergency room right away.
• Do not stop taking Colcrys even if you start to feel better, unless your healthcare provider tells you.
• Your healthcare provider may do blood tests while you take Colcrys.
• If you take Colcrys daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
• If you have a gout flare while taking Colcrys daily, report this to your healthcare provider.

Take Colcrys exactly as your doctor prescribes it. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

Gout flares: 

• Prevention: Typical dose is 0.6 mg (1 tablet) once or twice daily in patients over 16 years of age.  Maximum daily dose is 1.2 mg (2 tablets) per day.
• Treatment: Typical dose is 1.2 mg (2 tablets) at the first sign of a gout flare followed by 0.6 mg (1 tablet) one hour later.

Familial Mediterranean fever (FMF): 

• 12 years or older: Typical dose is 1.2 to 2.4 mg (2 to 4 tablets) given in one or two divided doses.
• 6 to 12 years old: Typical dose is 0.9 to 1.8 mg (1 & 1/2 to 3 tablets) given in one or two divided doses.
• 4 to 6 years old: Typical dose is 0.3 to 1.8 mg (1/2 to 3 tablets) given in one or two divided doses.

If you take too much Colcrys call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Colcrys is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep Colcrys at controlled room temperature.
• Keep Colcrys in tightly sealed container, out of the light.
• Keep this and all medicines out of the reach of children.