Foclivia: Uses, Side Effects and Dosage

What is FOCLIVIA used for?

FOCLIVIA® is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic situation in individuals 6 months of age and older.

Pandemic flu is a type of influenza that happens infrequently, but spreads rapidly around the world. It is caused by a new influenza virus to which people have no prior immunity. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.

How does FOCLIVIA work?

Like other influenza vaccines, FOCLIVIA® causes the body to produce antibodies against the virus. However, FOCLIVIA® contains an additional ingredient, “an adjuvant,” that helps to boost your body’s production of antibodies. This means that when your body is exposed to the flu virus, your body is more effective at defending itself.

The vaccine is given by injection with a needle in the upper arm and will require two doses given three weeks apart. Individuals may not be optimally protected until after receiving the second dose of the vaccine.

You cannot catch influenza from the vaccine, since it only contains portions of the virus, and not the whole live virus.

As with all vaccines, FOCLIVIA® may not fully protect all persons who are vaccinated.

What are the ingredients in FOCLIVIA®?

Medicinal ingredients:

Each 0.5 mL dose of the vaccine contains 7.5 mcg hemagglutinin (HA) from the following influenza strain:

• A/Vietnam/1194/2004 (H5N1) strain.

Non-medicinal ingredients:

• calcium chloride dihydrate,
• cetyltrimethylammonium bromide (CTAB)*,
• disodium phosphate dihydrate,
• egg proteins, including ovalbumin*,
• formaldehyde*,
• hydrocortisone*,
• kanamycin sulphate*,
• magnesium chloride hexahydrate,
• neomycin sulphate*,
• potassium chloride,
• potassium dihydrogen phosphate,
• sodium chloride,
• thimerosal**,
• water for injections

*Residuals

**Thimerosal is included in multi-dose vials only.

Adjuvant (MF59C.1): Citric acid monohydrate, polysorbate 80, sodium citrate dihydrate, sorbitan trioleate, squalene.

The tip cap and plungers of the pre-filled syringe and the multi-dose vial stopper are not made with natural rubber latex. FOCLIVIA® is considered safe for use in persons with latex allergies.

FOCLIVIA® comes in the following dosage forms:

FOCLIVIA® is supplied as a suspension for intramuscular injection in either a 0.5 mL single-dose, pre-filled syringe or a 5 mL multi-dose vial.

Do not use FOCLIVIA®:

if you or your child:

• have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of FOCLIVIA®,

• are allergic to:

  kanamycin sulfate (antibiotic), neomycin sulfate (antibiotic), formaldehyde, cetyltrimethylammonium bromide, hydrocortisone or polysorbate 80.

  Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

However, in a pandemic situation, you may still be given the vaccine, provided that medical treatment is available, in case you have an allergic reaction.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you are given FOCLIVIA®. Talk about any health conditions or problems you may have, including if you or your child:

• have or have had a reaction to vaccination with any of the following:

  • severe allergic reaction
  • difficulty breathing
  • swelling of the throat
  • fainting or collapse
  • fits or convulsions
  • high temperature (greater than 38.5°C)
• have an infection or temperature higher than 38.5°C. Your doctor may decide to delay vaccination until the illness has passed. A minor illness such as a cold is not usually a reason to delay vaccination.
• have a bleeding problem, bruise easily or use a blood thinning medication
• have low immunity due to treatment with certain medicines
• have allergies to other medicines or substances

• are pregnant or breastfeeding. Your healthcare professional will be able to discuss the potential risks and benefits of having FOCLIVIA® while you are pregnant or breastfeeding.

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 FOCLIVIA®:

• Immunosuppressive or corticosteroid therapies may lower your immune response to this vaccine
• If co-administration with another vaccine is indicated, immunization should be carried out on separate limbs.

How FOCLIVIA® is given:

FOCLIVIA® is given as an injection into a muscle, usually in the upper arm.

Usual dose:

Individuals 6 months of age and older: Two 0.5 mL doses administered with an interval of at least 21 days between doses. It is very important that you return for the second injection, or the vaccine may not work as well.

Overdose:

What are possible side effects from using FOCLIVIA®?

These are not all the possible side effects you may have when receiving FOCLIVIA®. If you experience any side effects not listed here, tell your healthcare professional.

The following are common or very common side effects of FOCLIVIA®. Most of these side effects are mild and disappear within 1-2 days without treatment. Tell your doctor if you or your child have side effects that bother you:

• Injection site pain, reddening, hardening, swelling or bruising
• Headache
• Muscle or joint pain
• Tiredness
• Feeling unwell
• Shivering
• Sweating
• Nausea
• Fever

The following additional side effects were reported commonly or very commonly in children 6 months to 3 years of age:

• Unusual crying
• Irritability
• Sleepiness
• Diarrhea
• Change in eating habits
• Vomiting
• Unusual sweating

The following additional side effects were reported for another influenza vaccine containing the same MF59^® adjuvant during the 2009 Influenza A (H1N1) pandemic.

• Swelling of the glands in the neck, armpit or groin (lymphadenopathy)

• Allergic reactions (which may occur immediately):

  • leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock) in rare cases,
  • may include symptoms of swelling of the face, lips, tongue or throat.
• Pain situated on the nerve route (neuralgia), abnormalities in the perception of touch, pain, feelings of pins and needles (paraesthesia), fits (convulsions)
• Dizziness, drowsiness, fainting, feeling about to faint (syncope, presyncope)Skin reactions that may spread throughout the body including itchiness of the skin (pruritus), rash and hives (urticaria)
• Muscular weakness and pain in the extremities
• Cough

Serious side effects and what to do about them

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

If you experience a severe allergic reaction, call the local emergency number or go to the nearest hospital.

Storage:

Store in a refrigerator between 2° to 8°C. Do not freeze. Discard if the vaccine has been frozen. Protect from light. Do not use after the expiration date. Return the multi-dose vial to the recommended storage conditions between uses.

Keep out of reach and sight of children.

If you want more information about FOCLIVIA®:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.seqirus.ca or by calling 1-855-358-8966.

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