Patient Medication Information: uses, side effects, how to take - Kepivance
ABOUT THIS MEDICATION
What the medication is used for:
Kepivance® (palifermin) is used to decrease the incidence and duration of oral mucositis (severe mouth sores) that is a side effect of some cancer treatments. Kepivance® is used to treat the mouth and throat soreness, which can improve your ability to swallow, eat, drink, talk, and sleep.
What it does:
Kepivance® is a man-made form of keratinocyte growth factor (KGF). KGF, also known as palifermin, is a substance that is naturally produced by the body. It stimulates the production and growth of certain skin cells, called epithelial cells that form the lining of your mouth, digestive tract and other skin tissues in the body.
When it should not be used:
Kepivance® should not be used in patients with known hypersensitivity (allergy) to certain proteins derived from E. coli, to palifermin, or any of the components of the product. For a complete listing, see What the important nonmedicinal ingredients are.
What the medicinal ingredient is:
The medicinal ingredient is palifermin.
What the important nonmedicinal ingredients are:
The nonmedicinal ingredients are L-histidine (an amino acid), mannitol (a type of sugar), polysorbate 20 (a moisturising agent) and sucrose (a type of sugar).
What dosage form it comes in:
Kepivance® is available as a sterile freeze-dried powder for reconstitution and intravenous injection. Each vial contains 6.25 mg of palifermin.
WARNINGS AND PRECAUTIONS
Kepivance® should not be used within 24 hours before, during infusion of, or within 24 hours after administration of chemotherapy. Kepivance® should also not be used in combination with heparin.
Kepivance should not be used in children under 18 years of age
There may be a risk that Kepivance treatment could lead to cataracts (a clouding of your vision) in some patients.
Your doctor will be experienced in the use of Kepivance® and anti-cancer medicines.
There have not been studies on the use of Kepivance® in pregnant women. Kepivance® should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the unborn infant.
The safety and efficacy of Kepivance® have not been established in patients with all types of cancers. The effect of Kepivance® on some types of tumors which may react to KGF stimulation is also not known. The use of Kepivance with melphalan (a drug used to treat multiple myeloma, a type of cancer), is not recommended.
INTERACTIONS WITH THIS MEDICATION
Kepivance® has been observed to interact with heparin (a blood thinner) in the laboratory, but this interaction is not known to decrease the effectiveness of Kepivance®. Nevertheless, ; heparin and Kepivance® should generally not be used together.
PROPER USE OF THIS MEDICATION
Usual dose:
The usual dose is 60 g/kg/day, given by intravenous injection for 3 days before and 3 days after chemotherapy.
At least 24 hours should be allowed between the administration of Kepivance® and the chemotherapy infusion.
Overdose
| 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. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Possible side effects include skin and oral (mouth) reactions (eg., rash, redness of the skin, itching, swelling, mouth / tongue thickness or discoloration, taste disorders). If you experience any of these reactions or other adverse reactions, you should report them to your doctor. Also, if you experience any changes in vision, please notify your doctor.
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 | |
| Only if severe | In all cases | ||
Common: Skin and oral reactions (eg., rash, redness of the skin, itching, swelling, mouth / tongue thickness or discoloration, taste disorders); Uncommon: Anaphylaxis (a severe allergic reaction that can occur rapidly); Hypersensitivity (another type of allergic reaction) | |||
This is not a complete list of side effects. For all other common / uncommon side effects, please refer to the Product Monograph. For any unexpected effects while taking Kepivance®, contact your doctor or pharmacist.
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:
Canada Vigilance Program Health Canada Postal Locator 00701D Ottawa, Ontario K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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. |
HOW TO STORE IT
Kepivance® should be stored refrigerated at 2o to 8oC (36o to 46oF); vials should be kept in their carton to protect them from light until time of use.
When dissolved, Kepivance® contains no preservative and is intended for single use only; therefore, it should be administered immediately (within 3 hours). However, when handled by a health care professional under very clean conditions, Kepivance® may be kept in the refrigerator, in the carton, at 2o to 8oC (36o to 46oF) for up to 24 hours. Before injection, Kepivance® may be allowed to reach room temperature for a maximum of 1 hour, but should be protected from light. It should not be shaken or frozen. Keep out of reach of children.
MORE INFORMATION
This document plus the full product monograph prepared for health professionals can be obtained by contacting the sponsor,
Swedish Orphan Biovitrum AB (publ) at
1-866-773-5274