Eptotermin alfa

Animal studies were conducted that cannot rule out effects of anti-OP-1 antibodies on embryo-foetal development. Due to the unknown risks to the foetus associated with the potential development of neutralizing antibodies to OP-1 protein, eptotermin alfa should not be used during pregnancy unless the potential benefit justifies the potential risks to the foetus.

In animal studies, excretion of IgG class anti-OP-1 antibodies into milk has been shown. As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-fed during eptotermin alfa therapy. Eptotermin alfa should be given to breast-feeding women only when the attending physician decides that the benefits outweigh the risks. It is recommended that breast-feeding be discontinued following treatment.

Women of child-bearing potential

Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with the medicine. Contraception in males and females Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment.

Fertility

There is no evidence to suggest that eptotermin alfa alters fertility.

Not relevant.

The following list of adverse reactions was compiled from those observed and recorded during clinical trials. A similar pattern of adverse reactions has been recorded from spontaneous reporting with an incidence significantly less than that seen in the clinical trials. Some patients treated with this product were also reported to have experienced various undesirable effects associated with recent orthopaedic surgery.

The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).

Musculoskeletal and connective tissue disorders: Bone formation increased (Heterotopic ossification/Myositis ossificans)

Investigations: Antibody test positive (Antibody formation)

Injury, poisoning and procedural complications: Postoperative wound site erythema (Erythema), Post procedural tenderness (Tenderness), Post procedural swelling (Swelling)