UK MHRA: Information sent to HCPs in August 2014 about the safety of medicines

Rienso is now contraindicated in patients with a history of drug allergy, including hypersensitivity to other parenteral iron products. Only give Rienso as an intravenous infusion over at least 15 minutes and never by injection. Place patients in a reclining or semi-reclining position during Rienso infusion and for at least 30 minutes thereafter. Carefully monitor patients for signs and symptoms of hypersensitivity reactions, including monitoring of blood pressure and pulse, during and for at least 30 minutes after infusion. Tell patients that if they start to feel unwell, they should inform their doctor/nurse immediately. As previously communicated, Rienso should only be administered by staff trained to recognize and manage anaphylactic reactions and in an environment with resuscitation facilities immediately available.

Prolia is associated with a risk of osteonecrosis of the jaw and hypocalcaemia.

Before prescribing Prolia, evaluate all patients for risk factors for osteonecrosis of the jaw. A dental examination with appropriate preventive dentistry is recommended in patients with risk factors. Encourage patients to maintain good oral hygiene, receive routine dental check-ups and immediately report any oral symptoms such as dental mobility, pain or swelling while receiving Prolia.

The risk of hypocalcaemia increases with the degree of renal impairment. Existing hypocalcaemia must be corrected before starting Prolia treatment. It is important that all patients taking Prolia have an adequate intake of calcium and vitamin D. This is especially important in patients with severe renal impairment. Monitor calcium levels before and during Prolia treatment, as described in the letter. Tell patients to report symptoms of hypocalcaemia.

XGEVA is associated with a risk of osteonecrosis of the jaw and hypocalcaemia.

A dental examination with appropriate preventive dentistry is recommended before prescribing XGEVA. Do not start XGEVA in patients with a dental or jaw condition requiring surgery, or in patients who have not recovered following oral surgery. Encourage patients to maintain good oral hygiene, receive routine dental check-ups and immediately report any oral symptoms such as dental mobility, pain or swelling while receiving XGEVA.

The risk of hypocalcaemia increases with the degree of renal impairment. Existing hypocalcaemia must be corrected before starting XGEVA treatment. Unless they have hypercalcaemia, tell patients to take calcium and vitamin D supplements during XGEVA treatment. This is especially important in patients with severe renal impairment. Monitor calcium levels before and during XGEVA treatment, as described in the letter. Tell patients to report symptoms of hypocalcaemia.