Patient Medication Information: uses, side effects, how to take - Cyanokit (Emd Serono, A Division of Emd Inc., Canada)

ABOUT THIS MEDICATION

What the medication is used for:

Cyanokit is an emergency treatment (antidote) used in patients with known or suspected cyanide poisoning. Cyanide is a highly poisonous chemical. Cyanide poisoning can happen from:

breathing smoke from household and industrial fires
breathing or swallowing cyanide
having your skin exposed to cyanide

What it does:

The active ingredient in Cyanokit, hydroxocobalamin, binds to cyanide that is present in the blood, making it less toxic. The complexed cyanide is then renally excreted from the body.

What the medicinal ingredient is:

hydroxocobalamin

What the important non medicinal ingredients are:

Cyanokit contains hydrochloric acid which is included to help maintain the correct pH of the reconstituted solution.

What dosage forms it comes in:

Cyanokit (2.5 g) consists of two vials, each containing 2.5 g hydroxocobalamin powder. Each vial is then reconstituted in 100mL of liquid for intravenous administration.

Cyanokit (5 g) consists of one vial, containing 5 g hydroxocobalamin powder which is then reconstituted in 200mL of liquid for intravenous administration.

WARNINGS AND PRECAUTIONS

Serious side effects may include:

allergic reactions. Signs of a serious allergic reaction include chest tightness, trouble breathing, swelling, hives, itching, and a rash.
increased blood pressure

BEFORE you are administered Cyanokit, talk to your doctor or pharmacist:

If you are allergic to hydroxocobalamin or vitamin B₁₂. They will have to take this into account before treating you with Cyanokit.
If you are pregnant. Cyanokit can be administered during pregnancy. Tell your doctor as soon as possible if you
- were pregnant or think you may have been pregnant during treatment with Cyanokit.
- If you are breastfeeding. However, Cyanokit can be administered during breast feeding. You will be recommended to stop breastfeeding after treatment with Cyanokit.

AFTER you are administered Cyanokit, tell your doctor or pharmacist:

That you have been treated with Cyanokit if you need to have any blood or urine tests. Cyanokit may modify the results to these tests.
If you are pregnant of become pregnant after Cyanokit treatment as the product remains in the body for some time and may harm the fetus.
Women of childbearing age: your doctor will recommend you to practice adequate methods of contraception following Cyanokit treatment.
If you later suffer a skin burn within 2 weeks of administration of Cyanokit and are being assessed by a healthcare professional (HCP), tell the HCP that you have taken Cyanokit, a product which can cause the skin to redden and interfere with the burn assessment.

Be cautious when using Cyanokit with other cyanide antidotes, since the safety of such combined treatment is not known. If the decision is made to administer another cyanide antidote with Cyanokit, these drugs must not be administered concurrently in the same intravenous lines.

INTERACTIONS WITH THIS MEDICATION

No drug interactions studies have been performed for Cyanokit. However, treatment with Cyanokit can interfere with certain laboratory tests for up to 48 hours after treatment.

Treatment with Cyanokit may lead to accidental shut down of haemodialysis machines due to the deep red colour given to the blood plasma by the product. A safety feature in the machine may recognize the deep red colour as failure in the system and shut down.

PROPER USE OF THIS MEDICATION

Usual Adult dose:

Cyanokit (5 g dose) after reconstitution is administered through a vein (intravenous or IV) over 15 minutes by an emergency care provider or doctor. A second 5 g dose may be given to you if needed.

Overdose:

The maximum recommended dose is 10 g. Doses as high as 15 g have been administered without does-specific adverse reactions being reported. If you feel you have been administered too much (too many doses) of Cyanokit, talk to your attending healthcare provider, or another doctor, even if there are no symptoms.

IMPORTANT: PLEASE READ

CYANOKIT Product Monograph Page 31 of 31

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects with Cyanokit may include:

red coloured urine
red coloured skin and mucous membranes, acne like rash
nausea, vomiting, diarrhea, bloody stools, trouble swallowing, stomach pain
throat tightness, dry throat
headache, dizziness, memory problems, restlessness
infusion site reaction
eye swelling, irritation, or redness
swelling of feet and ankles
irregular heart heat, increased heart rate
fluid in lungs
kidney problems

After treatment with Cyanokit:

Skin redness may last up to 2 weeks. Avoid sun exposure while your skin is red. Urine redness may last up to 5 weeks.
An acne-like rash may appear 7 to 28 days after treatment with Cyanokit. This rash usually goes away without any treatment.
Talk to your doctor if you breastfeed. Cyanokit may pass into your breast milk and your doctor will recommend you to stop breastfeeding.
Talk to your doctor about any side effect that bothers you or that does not go away.

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 call your doctor or pharmacist
Symptom / effect	Only if severe	In all cases
Common	Increased Blood Pressure		Τ
Uncommon	Allergic reaction (signs may include swelling, breathing difficulties, skin redness, urticaria (hives) or itching)		Τ

This is not a complete list of side effects. For any unexpected effects while taking Cyanokit, contact your doctor or pharmacist.

HOW TO STORE IT

Store Cyanokit at 25 ºC; excursions permitted to 15-30ºC.

Once reconstituted, the solution can be stored for up to 6 hours at a temperature between 2ºC and 40ºC. Discard any unused portion after 6 hours.

Keep out of reach 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:

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 0701D
  Ottawa, ON 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 plus the full product monograph, prepared for health professionals can be found at:

http://webprod.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp

Rx or OTC	Prescription (Rx)?
DIN	02360721
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Hydroxocobalamin 2.5 G
Dosage form(s)	Powder For Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	V Various drug classes V03 All other therapeutic products V03A All other therapeutic products V03AB Antidotes V03AB33 Hydroxocobalamin
Company	EMD SERONO, A DIVISION OF EMD INC., CANADA
Current status	Cancelled Post Market
Current status date	September 30, 2014

Cyanokit (Emd Serono, A Division of Emd Inc., Canada): Uses, Side Effects and Dosage