Patient Medication Information: uses, side effects, how to take - Mylan-Anagrelide

ABOUT THIS MEDICATION

What the medication is used for:

Mylan-Anagrelide is prescribed for the treatment of patients with thrombocythemia secondary to myeloproliferative disorders. Thrombocythemia is a condition in which there are too many platelets (the little cells which help the blood to clot) in the blood. Myeloproliferative disorders are diseases in which one or more of the types of cells that make up the blood are being overproduced.

Lowering platelet counts results in improving symptoms, including serious symptoms related to blockages in blood vessels and bleeding.

Mylan-Anagrelide is intended for long-term usage and has not been evaluated for treatment of the short-term life threatening complications of having too many platelets in the blood.

What it does:

The way that Mylan-Anagrelide works in the body to reduce your platelet count is not fully understood. Mylan-Anagrelide is believed to reduce the number of platelets by affecting megakaryocytes (the cells that produce platelets). Its action slows down platelet production.

Although Mylan-Anagrelide lowers platelet counts to more normal levels, it does not affect the body's natural process to clot blood when needed.

When it should not be used:

You should not take Mylan-Anagrelide if you:

Have severe liver disease
Are allergic to anagrelide or any of the other nonmedicinal ingredients (see What the nonmedicinal ingredients are:) in Mylan-Anagrelide or its container.

What the medicinal ingredient is:

anagrelide hydrochloride

What the nonmedicinal ingredients are:

Black iron oxide, crospovidone, gelatine, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicone dioxide, sodium lauryl sulphate,

titanium dioxide

What dosage forms it comes in:

Capsule 0.5mg

WARNINGS AND PRECAUTIONS

BEFORE you use Mylan-Anagrelide talk to your doctor or pharmacist if:

You were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes in your blood e.g., potassium, magnesium or calcium
You have heart, lung, liver or kidney disease
You are pregnant or planning a pregnancy
You are breast feeding.

Mylan-Anagrelide is not recommended in women who are or may become pregnant.

Limited data are available in patients under the age of 16 years.

Caution should be used when driving vehicles or machinery.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about any medication that you are taking, including non-prescription medications and natural health products.

Drugs that may interact with Mylan-Anagrelide include:

medicines that can alter your heart rhythm
acetylsalicylic acid
fluvoxamine
omeprazole
theophylline
milrinone
sucralfate
CYP1A2 substrates/inhibitors

If Mylan-Anagrelide is taken in combination with acetylsalicylic acid (ASA), there is an increased risk of major bleeding. Before starting treatment, your doctor will consider for you the potential risks and benefits of using Mylan-Anagrelide with acetylsalicylic acid (ASA). If, for any reason, you already have an increased risk of bleeding, you should talk to your doctor.

Grapefruit juice may also interact with Mylan-Anagrelide. Food may slow down the rate at which Mylan-Anagrelide is absorbed into your body.

PROPER USE OF THIS MEDICATION

Usual Dose:

Take as directed by your doctor.

Your doctor may check for heart disease before starting you on Mylan-Anagrelide.

Regular blood tests will be done at the start of your treatment and then at intervals. This will help your doctor monitor the liver’s response to Mylan-Anagrelide and that Mylan-Anagrelide is working for you. If you have kidney or liver problems, your doctor will monitor their function while you are taking Mylan-Anagrelide.

Overdose:

Possible symptoms of an overdose of anagrelide could include low platelet count, which can potentially cause bleeding.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose at the beginning of your treatment, contact your doctor or pharmacist.

If you miss a dose during your long-term treatment, take the missed dose as soon as possible, unless it is almost time for your next dose. Skip the missed dose if it is almost time for your next regular dose. Do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects with Mylan-Anagrelide are:

Abdominal pain, back pain, cough, digestive problems, headache, diarrhea, fatigue, fever, gas, loss of appetite, malaise, nausea, pain, redness and itching of skin, sore throat, tingling, vomiting, whirling sensation.

You may also experience: bruises, chills, constipation, dry mouth, ear problems (ringing in the ear), flushing, flu symptoms, hair loss, infection, infection of the sinuses, insomnia (difficulty falling asleep), muscle and bone pain, neck pain, nervousness, respiratory disease, changes in weight, skin problems, sweating.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist		Stop taking drug and seek immediate medical help
Symptom / effect		Only if severe	In all cases	Stop taking drug and seek immediate medical help
Very Common	Chest pain		√
	Palpitations: Pounding or irregular heartbeat		√
	Edema: swelling in your feet or ankles		√
	Trouble breathing or shortness of breath			√
Common	Bleeding		√
	Blood in your stools or urine		√
	Blood Clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations			√
	Confusion		√
	Dehydration		√
	Depression: inability to concentrate, low mood		√
	Asthma: difficulty breathing		√
	Difficulty swallowing		√
	Fast or irregular heartbeat		√
	Respiratory Infection (pneumonia or bronchitis): fever, cough, chest pain and shortness of breath		√

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist		Stop taking drug and seek immediate medical help
Symptom / effect		Only if severe	In all cases	Stop taking drug and seek immediate medical help
Common	High blood pressure		√
	Irritation or infection of the eye	√
	Loss of consciousness			√
	Loss of memory		√
	Low blood pressure: lightheaded, dizzy, shortness of breath or fainting; may occur when you go from lying or sitting to standing up		√
	Nose bleeding		√
	Heart disease or heart failure: swollen legs or ankles or difficulty breathing			√
	Trouble with vision		√
	Urinary problems		√
Uncommon	Ventricular tachycardia : irregular and abnormally fast heart beat			√
Frequency not known*	Allergic lung conditions: coughing, severe trouble breathing, shortness of breath, fever, chills, body aches			√
Frequency not known*	Liver disorder: nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark urine and unusual tiredness		√

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist		Stop taking drug and seek immediate medical help
		Only if severe	In all cases
Frequency not known*	Kidney disorder: decreased urination, nausea, vomiting, swelling of extremities, fatigue		√
	Torsades de pointes: life- threatening irregular heart rhythm, dizziness, fainting			√

* Frequency of event cannot be determined from available data. This is not a complete list of side effects. For any unexpected effects while taking Mylan-Anagrelide, contact your doctor or pharmacist.

HOW TO STORE IT

Store from 15°C to 25°C in a light-resistant container. Keep out of reach and sight of children.

REPORTING SUSPECTED 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 3 ways:

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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, Ontario
  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™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 can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Revised on: February 14, 2014

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-800-575-1379

Rx or OTC	Prescription (Rx)?
DIN	02253054
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Anagrelide (anagrelide hydrochloride) 0.5 MG
Dosage form(s)	Capsule
Route(s) of administration	Oral
Drug class (WHO ATC)	L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01X Other antineoplastic agents L01XX Other antineoplastic agents L01XX35 Anagrelide
Company	MYLAN PHARMACEUTICALS ULC
Current status	Cancelled Post Market
Current status date	June 28, 2016

Mylan-Anagrelide: Uses, Side Effects and Dosage