Patient Medication Information: uses, side effects, how to take - Octagam 5%

ABOUT THIS MEDICATION

What the medication is used for:

OCTAGAM is used for replacement therapy in the following:

Primary immunodeficiency (PID) syndromes

congenital agammaglobulinaemia and hypogammaglobulinaemia
common variable immunodeficiency
severe combined immunodeficiencies

Secondary immunodeficiency syndromes

secondary hypogammaglobulinaemia in patients with chronic lymphocytic leukaemia (CLL), or multiple myeloma (MM) with recurrent infections
children with congenital AIDS who have bacterial infections

What it does:

The mechanism of action in indications other than replacement therapy is not fully understood, but includes immunomodulatory effects.

This product can help prevent infections by providing a protective role in diseases where patients suffer from a poorly functioning immune system.

When it should not be used:

OCTAGAM should not be used if:

You have a history of an allergic reaction to any human immunoglobulin preparation.
You have immunoglobulin A (IgA) deficiency, with known antibodies against IgA.
You are allergic to any of the components of the preparation.

What the medicinal ingredient is:

Immunoglobulin Intravenous (Human), 5%

What the important nonmedicinal ingredients are:

Maltose, Triton X-100, TNBP, Water for Injections, IgA

What dosage forms it comes in:

OCTAGAM is a 50 mg/mL solution for intravenous infusion and comes in the following dosage forms:

1 infusion bottle with 50 mL

1 infusion bottle with 100 mL

1 infusion bottle with 200 mL

1 infusion bottle with 500 mL

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

As with all Immunoglobulin Intravenous formulations this product is made from human plasma, which may contain the infectious agents such as viruses that cause hepatitis and other viral diseases. Stringent steps are in place during the collection of human plasma and product manufacturing to ensure the viral safety of human plasma based products. In the particular case of OCTAGAM 5% viral safety has been increased by having included two steps of viral inactivation/removal in the manufacturing process. Your doctor should discuss the risks and benefits of this product with you before giving you this product.

Warning: Thromboembolic events

Thromboembolic events such as heart attack, stroke, and obstructions of a deep vein e.g. in the calves or of a blood vessel in the lung (pulmonary embolism) may occur with administration of human immunoglobulin intravenous (IGIV) products.
Thromboembolic events occur more commonly in patients with pre-existing risk factors for thrombo-embolism receiving IGIV products.
In general the risk factors for thromboembolic events include: obesity; advance age; hypertension; diabetes mellitus; previous events of heart attack, stroke, and obstructions of a deep vein etc.; prolonged periods of immobilisations; intake of certain hormones (e.g. the pill);.
Thrombosis may occur even in the absence of known risk factors.
In the particular case of OCTAGAM 5% specific additional measures have been implemented to reduce the risk of thromboembolic events and to ensure the quality and therefore the safe use of OCTAGAM. Nevertheless, patients with known risk factors should ensure a balanced fluid intake; moreover the product needs to be administered at a slow speed.

BEFORE you use OCTAGAM talk to your doctor or pharmacist if:

You recently have heart disease or have had blood clots.
If you are pregnant or nursing.
You have the following risk factors: kidney disease diabetes mellitus, seriously dehydrated, overweight, take kidney damaging medications or over the age of 65.
You are allergic to the active substance or to any of the nonmedicinal ingredients.
You have a history of allergy to corn products.
You use any device to measure blood or urine glucose, as the maltose in this product may interfere with these measurements.

INTERACTIONS WITH THIS MEDICATION

There is no known drug interaction to OCTAGAM. OCTAGAM administration may slow the protection of live attenuated viral vaccines such as measles, mumps, rubella and varicella for at least six weeks, and possibly up to three months or longer.

The infusion line may be flushed before and after administration of OCTAGAM with either normal saline or 5% dextrose in water.

Components used in the packaging of OCTAGAM are latex-free.

PROPER USE OF THIS MEDICATION

Usual dose:

Your doctor will determine the dose(s) of OCTAGAM that you are to receive as an infusion, which is an injection given slowly in a vein. The dose you receive will depend on your clinical situation and disease, but the following are a generally accepted starting dose of OCTAGAM:

Primary Immunodeficiencies – Monthly doses of at least 100 mg/kg are recommended.

Secondary Immunodeficiencies – The recommended dose is 0.2 - 0.4 g/kg body weight every 3 – 4 weeks.

It is recommended that OCTAGAM be infused at a rate of 30 mg/kg/hour for the first 30 minutes; if tolerated, advanced to 60 mg/kg/hour for the second 30 minutes; and if tolerated, advanced to 120 mg/kg/hour for the third 30 minutes. Thereafter the infusion could be maintained at a rate up to, but not exceeding, 200 mg/kg/hour.

Filtration of OCTAGAM is not required.

Overdose:

Overdose is possible in patients that are overweight, elderly, or those with impaired kidney function.

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

Missed Dose:

Not applicable.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include: rigors (chills), fever, headache, muscle pain including back or chest pain, flushing, nausea, allergic reactions (such as changes in blood pressure, difficulty breathing a blue discoloration of the skin or mucous membranes, fast heart rate), dizziness, fatigue, drowsiness, skin reactions (such as rash, itching, hives), temporary meningitis (reversible aseptic meningitis), temporary decrease of red blood cells (reversible haemolytic anaemia/haemolysis), abdominal pain, diarrhoea and vomiting.

The following symptoms may be signs of thromboembolic events: chest pain or pressure, vision or speech disorder, one-sided paralysis/weakness, movement disorder, pain or tenderness in leg(s) or calf(s), swelling in calf(s) or lower leg(s) or cyanosis. If any of those symptoms occur, please talk to 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
Symptom / effect	Only if severe	In all cases
Common	allergic type of reaction headache nausea fever	T T T	T	T T T
Uncommon	skin reactions incl. hives back or chest pain chills		T T T	T T T
Very rare	shock swelling of tongue or face migraine dizziness heart pain beating of the heart fall or increased blood pressure difficulties in breathing or cough vomiting diarrhoea belly pain	T	T T T T T T T T T T	T T T T T T T T T T T

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

HOW TO STORE IT

Store refrigerated or at room temperature (+2 °C to +25 °C). Warm up to room or body temperature before use. Do not freeze. Protect from light. Discard any remaining contents after use. Do not use after expiry date.

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:

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

http://www.octapharma.com

or by contacting Octapharma Canada Inc.,

at: 1-888-438-0488

DIN	02267713
Schedule(s)	SCHEDULE D
Active ingredient(s)	Immunoglobulin (human) 50 MG
Dosage form(s)	Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	J Antiinfectives for systemic use J06 Immune sera and immunoglobulins J06B Immunoglobulins J06BA Immunoglobulins, normal human J06BA02 Immunoglobulins, normal human, for intravasc. adm.
Company	OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H
Current status	Approved
Current status date	June 27, 2005

Octagam 5%: Uses, Side Effects and Dosage