Sandoz Anagrelide: Uses, Side Effects and Dosage

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

What the medication is used for:

What it does:

When it should not be used:

What the medicinal ingredient is:

What the non-medicinal ingredients are:

What dosage forms it comes in:

WARNINGS AND PRECAUTIONS

INTERACTIONS WITH THIS MEDICATION

ABOUT THIS MEDICATION

PROPER USE OF THIS MEDICATION

Usual Dose:

Overdose:

Missed Dose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

HOW TO STORE IT

Reporting Side Effects

MORE INFORMATION

If you want more information about Sandoz Anagrelide:

Last revised:

Sandoz Anagrelide is prescribed for the treatment of patients with thrombocythemia secondary to myeloproliferative neoplasms. Thrombocythemia is a condition in which there are too many platelets (the little cells which help the blood to clot) in the blood. Myeloproliferative neoplasms 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.

Sandoz 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.

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

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

You should not take Sandoz Anagrelide if you:

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

Anagrelide hydrochloride

Crospovidone, Lactose, Magnesium Stearate, Microcrystalline Cellulose and Povidone. Capsule shells contain Gelatin, Silicon Dioxide, Sodium Lauryl Sulfate, and Titanium Dioxide.

Capsule: 0.5 mg

Before you use Sandoz 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.

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

Use of anagrelide with acetylsalicylic acid (ASA) has been associated with risk of major bleeding events.

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

Caution should be used when driving vehicles or machinery.

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 Sandoz Anagrelide include:

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

If Sandoz 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 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 Sandoz Anagrelide. Food may slow down the rate at which Sandoz Anagrelide is absorbed into your body.

Take as directed by your doctor.

Your doctor may check for heart disease before starting you on Sandoz 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 Sandoz Anagrelide and that Sandoz Anagrelide is working for you. If you have kidney or liver problems, your doctor will monitor their function while you are taking Sandoz Anagrelide.

Possible symptoms of an overdose of anagrelide could include low platelet count, which can potentially cause bleeding and reduction in blood pressure.

If you think you have taken too much Sandoz Anagrelide, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.

The most common side effects with Sandoz 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 AND WHAT TO DO ABOUT
	THEM
Symptom / effect			Talk with your healthcare professional		Stop taking drug and seek immediate medical help
			Only if severe	In all cases
		Chest pain		✓
		Palpitations: Pounding or irregular heartbeat		✓
		Edema: Swelling in your feet or ankles		✓
		Trouble breathing or shortness of breath			✓
		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		✓
		High blood pressure		✓
		Hypoesthesia: Decreased or loss of feeling or sensation such as numbness		✓

	SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT
	THEM
Symptom / effect 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			Talk with your healthcare professional		Stop taking drug and seek immediate medical help
			Only if severe	In all cases
				✓
						✓
					✓
					✓
					✓
						✓
					✓
					✓
		Supraventricular tachycardia, Ventricular tachycardia: Irregular and abnormally fast heartbeat.			✓
		Pulmonary hypertension: Shortness of breath, swelling in legs or ankles or lips and skin can turn bluish colour			✓
		Allergic lung conditions: Coughing, severe trouble breathing, shortness of breath, fever, chills, body aches			✓
		Liver disorder: Nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark urine and unusual tiredness		✓

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

Store Sandoz Anagrelide between 15^oC and 30^oC in a light-resistant container. Protect from moisture. Keep out of reach and sight of children.

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-
canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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.

Talk to your healthcare professional

www.sandoz.ca

June

22, 2020

J4B 1E6

Boucherville, (QC), Canada

110 Rue de Lauzon

Sandoz Canada Inc.

Inc. at:

1-800-361-3062.

eng.jsp);

by contacting the sponsor, Sandoz Canada (https://health-products.canada.ca/dpd-bdpp/index- Information

by visiting the

Health Canada website healthcare professionals and includes this Consumer

•

Find the full product monograph

that is prepared for

Rx or OTC	Prescription (Rx)?
DIN	02260107
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Anagrelide (anagrelide hydrochloride monohydrate) 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	SANDOZ CANADA INCORPORATED
Current status	Cancelled Post Market
Current status date	February 4, 2020

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT
THEM

Symptom / effect
Kidney disorder: Decreased
urination, nausea, vomiting, swelling of extremities, fatigue
Torsades de
pointes:
Life-threatening irregular heart rhythm, dizziness, fainting
Prinzmetal
angina: painful spasm of the blood vessels on the heart (while resting, usually at night or early morning)

Talk with your healthcare professional

Stop taking drug and seek immediate medical help

Only if
severe

In all cases