Osigraft 3.3 mg powder for suspension for implantation

Osigraft is a type of medicine known as a bone morphogenetic protein (BMP). This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it. Osigraft is implanted in adult patients with fractures of the tibia which have failed to heal for at least 9 month duration in cases where treatment with autograft (transplanted bone from your hip) has failed or should not be used.

Do not use Osigraft

• if you are allergic to eptotermin alfa or collagen, the other ingredient of Osigraft (see section 6).
• if you are an adolescent and your skeleton is not yet fully formed (still growing). if you are a child (below 18 years old)
• if you have an autoimmune disease (disease arising from or directed against your own tissues), including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren?s syndrome and dermatomyositis/ polymyositis.
• if you have active infection at the site of non-union (inflammation and drainage at the site of injury) or active systemic infection.
• if your doctor determines that you have inadequate skin coverage (at the fracture site) and inadequate blood supply at your site of surgery.
• for vertebral (spine) fractures.
• for treating non-union resulting from pathological (disease-related) fractures, metabolic bone disease or tumours.
• when there are any tumours in the area of the non-union site.
• if you are receiving chemotherapy, radiation treatment or immunosuppression

Take special care with Osigraft

The following are precautions for use of Osigraft to be discussed with your doctor.

Osigraft stimulates the growth of new bone as part of the treatment of a fracture non-union and needs the support of specialised surgical devices to stabilise the broken bone while it heals.

Use of Osigraft does not guarantee repair; additional surgery may be required.

Special care is taken during surgery to prevent Osigraft leaking into the surrounding tissue in order to avoid the possibility of new bone growing outside the treated non-union location.

There is a possibility that new antibodies can form in your body after treatment with Osigraft. Antibodies are special proteins produced by the human body as part of the healing process in various diseases; one such illness is a virus infection. Antibodies often form as part of the body?s response to treatment with some medicines one of these is Osigraft. These newly formed antibodies have not been found to cause any harm to patients. You will be monitored by your doctor if there is any medical suspicion that new antibodies have formed.

Repeated use of Osigraft is not recommended because clinical trials of multiple surgical treatments at different times have not been undertaken in patients. Laboratory studies have shown that antibodies to the eptotermin alfa component of this medicine could react with similar antibodies that the body makes naturally. The long-term impact of these antibodies is not known.

The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation,infection and occasional migration of the implanted materials and is therefore not recommended.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Osigraft should not be used during pregnancy unless the expected benefits to the mother are thought to outweigh the possible risks to the unborn child. This is something that will be decided by your surgeon. Women of child-bearing potential should inform their surgeon of the possibility of pregnancy before undergoing treatment with Osigraft. Women of childbearing potential are advised to use effective contraception up to at least 12 months after treatment.

The potential for harm to the breast-feed infant is unknown. Women should not breast-feed during the period immediately following treatment with Osigraft. If you are a nursing mother you should be treated with Osigraft only if your physician or surgeon considers the benefits to you outweigh the risks to your child.

Important information about some of the ingredients of Osigraft

Osigraft contains bovine collagen. If you have a known hypersensitivity to collagen you should not be treated with this medicine.

Osigraft is only used by an appropriately qualified surgeon. This is usually done under a full general anaesthetic so you will not be awake during the surgery. Depending on the size of the gap in the broken bone one or two vials of Osigraft may be administered. During surgery Osigraft is placed directly at the injury site in contact with the damaged bone surfaces. The surrounding muscle tissues are closed around the implanted medicine as is the skin on the top of the muscle.

The maximum recommended dose for this medicine is 2 vials (2g) since its effectiveness at higher doses has not been established.

Like all medicines, Osigraft can have side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10)
• common (affects 1 to 10 users in 100)
• uncommon (affects 1 to 10 users in 1,000)
• rare (affects 1 to 10 users in 10,000)
• very rare (affects less than 1 user in 10,000)
• not known (frequency cannot be estimated from the available data

In clinical studies, the following undesirable effects have been reported:
Common reported side effects included:

• discoloration of the wound site,
• erythema (redness of the skin),
• tenderness, and swelling over the implant site,
• heterotopic ossification / myositis ossificans (bone formation outside of the fracture area).

If any of the side effects gets serious or if you notice any side effect not listed in this leaflet, please tell your doctor.

This medicine is only supplied to hospitals and specialist clinics. The hospital pharmacist or surgeon is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.

Keep out of the reach and sight of children.

This medicine should not be used after the expiry date which is printed on the carton and the blister.The expiry date refers to the last day of that month.
Store in a refrigerator at (2°C - 8°C).

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

What Osigraft contains

The active substance is eptotermin alfa (a recombinant human Osteogenic protein 1 produced in a recombinant Chinese hamster ovary (CHO) cell line). One vial of Osigraft contains 1 g of powder including 3.3 mg of eptotermin alfa and the excipient bovine collagen.

What Osigraft looks like and contents of the pack

Osigraft is supplied as white to off-white powder packaged in an amber coloured glass vial (pack size of 1) within a blister pack, comprised of a plastic tray and lid, in a carton.

Marketing Authorisation Holder and Manufacturer

Howmedica International S. de R. L.
Division of Stryker Corporation
Raheen Business Park
Limerick
Ireland

Tel +353-61-498200
Fax +353-61-498247

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