Patient Medication Information: uses, side effects, how to take - Daptomycin for Injection (Pfizer Canada)

What is Daptomycin for Injection used for?

Daptomycin for Injection is used to treat bacterial infections:

of the skin and soft tissues (patients 1 year and older)
in the blood (patients 1 year and older)
certain heart valve infections (patients 18 years and older)

Antibacterial drugs like Daptomycin for Injection treat only infections caused by bacteria. They do not treat viral infections. Although you may feel better early in treatment, Daptomycin for Injection should be used exactly as directed. Misuse or overuse of Daptomycin for Injection could lead to growth of bacteria that will not be killed by Daptomycin for Injection (resistance). This means that Daptomycin for Injection may not work for you in the future.

How does Daptomycin for Injection work?

Daptomycin for Injection are antibiotics. They work by killing certain bacteria that cause your infection.

What are the ingredients in Daptomycin for Injection?

Medicinal ingredients: Daptomycin

Non-medicinal ingredients: Sodium hydroxide

Daptomycin for Injection comes in the following dosage forms:

Lyophilized powder for solution available as 350 mg/vial and 500 mg/vial

Do not use Daptomycin for Injection if:

you are allergic to daptomycin.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Daptomycin for Injection. Talk about any health conditions or problems you may have, including if you:

have kidney or severe liver problems.
have high blood levels of creatine phosphokinase (CPK).
are pregnant, or planning on becoming pregnant.
are breast-feeding or plan to breast-feed. Breast-feeding should be stopped during treatment
with Daptomycin for Injection.
are allergic to any antibiotics or other drugs.
are taking other medications (see The following may interact with Daptomycin for Injection).
have any questions about your treatment, both before and during treatment.

Other warnings you should know about:

Stop taking Daptomycin for Injection and contact your doctor right away if you:

have severe or lasting diarrhea (bloody or watery) with or without
- fever.
- stomach pain or tenderness.

You may have Clostridium difficile colitis (bowel inflammation).

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Daptomycin for Injection:

Drugs that lower cholesterol (HMG-CoA reductase inhibitors also known as “statins” such as
atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin)
Tobramycin (another antibiotic)
Blood thinners (warfarin)

How to take Daptomycin for Injection:

Daptomycin for Injection will be given intravenously (injected into a vein) by a doctor or nurse in a hospital or clinical setting.

Usual dose:

Adults:

Serious skin infections: The usual adult dose is 4 mg for every kg of body weight, given as a solution that is injected into a vein. It is given every 24 hours for 7 to 14 days, over either a 30 minute period or a 2 minute period.

Bacterial infections in the blood, including certain heart valve infections: The usual adult dose is 6 mg for every kg of body weight, given as a solution that is injected into a vein. It is given every 24 hours for 10 to 42 days, either over a 30 minute period or a 2 minute period.

Children:

Your doctor will decide how much Daptomycin for Injection to give your child based on their age, weight and type of infection.

Serious skin infections:

Age Group	Dosage
Duration of Therapy
12 to 17 years	5 mg/kg once every 24 hours infused over 30 minutes
Up to 14 days
7 to 11 years	7 mg/kg once every 24 hours infused over 30 minutes
2 to 6 years	9 mg/kg once every 24 hours infused over 60 minutes
1 to less than 2 years	10 mg/kg once every 24 hours infused over 60 minutes

Bacterial infections in the blood:

Age Group		Dosage	Duration of Therapy
		12 to 17 years	7 mg/kg once every 24 hours infused over 30 minutes	Up to 42 days
7 to 11 years	9 mg/kg once every 24 hours infused over 30 minutes
1 to 6 years	12 mg/kg once every 24 hours infused over 60 minutes

Overdose:

What are possible side effects from using Daptomycin for Injection?

These are not all the possible side effects you may feel when taking Daptomycin for Injection. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

headache or dizziness.
diarrhea or constipation.
nausea or vomiting.
rash or itching.
difficulty sleeping.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional			Stop taking drug and get immediate medical help
				Only if severe	In all cases

If you think you have taken too much Daptomycin for Injection, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

UNCOMMON A serious allergic reaction with symptoms such as: shortness of breath, difficulty swallowing. hives, itching, drug rash, blister-like sores. swelling of the mouth, throat, lips and limbs (angioedema).		X
Pain in the hands and feet with symptoms such as: burning, "pins and needles", numbness. muscle pain, weakness or tiredness (myopathy).		X
Irregular heartbeat		X
Kidney problems with symptoms such as: reduced kidney function, kidney failure. increased urination, bloody urine. lower back pain, pressure in the bladder. fatigue and nausea.		X
VERY RARE Respiratory problems with symptoms such as: fever, cough, shortness of breath or difficulty breathing (eosinophilic pneumonia). Inflammation of the lungs (organizing pneumonia)		X

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

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

IMPORTANT: PLEASE READ

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.

Storage:

Daptomycin for Injection vials containing lyophilized powder should be stored at 2ºC to 8ºC.

Reconstituted solutions are to be used immediately or refrigerated (2ºC to 8ºC) and used within 72 hours, then discarded. Health Care professionals should refer to the Product Monograph for more details.

Keep out of reach and sight of children.

If you want more information about Daptomycin for Injection:

Talk to your healthcare professional
Find the full product monograph that is prepared for health professionals and includes this Patient Medication Information by visiting the Government of Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp), the manufacturer's website (http://www.pfizer.ca) or calling 1-800-463-6001.

Pfizer Canada ULC

Kirkland, Québec H9J 2M5

Last Prepared: May 3, 2019

Daptomycin for Injection (Pfizer Canada): Uses, Side Effects and Dosage