"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
- Advise patients to take Exjade once daily on an empty stomach at least 30 minutes prior to food, preferably at the same time every day. Instruct patients to completely disperse the tablets in water, orange juice, or apple juice, and drink the resulting suspension immediately. After the suspension has been swallowed, resuspend any residue in a small volume of the liquid and swallow [see DOSAGE AND ADMINISTRATION].
- Advise patients not to chew tablets or swallow them whole [see WARNINGS AND PRECAUTIONS].
- Caution patients not to take aluminum-containing antacids and Exjade simultaneously [see DRUG INTERACTIONS].
- Because auditory and ocular disturbances have been reported with Exjade, conduct auditory testing and ophthalmic testing before starting Exjade treatment and thereafter at regular intervals [see WARNINGS AND PRECAUTIONS].
- Caution patients experiencing dizziness to avoid driving or operating machinery [see ADVERSE REACTIONS].
- Caution patients about the potential for the development of GI ulcers or bleeding when taking Exjade in combination with drugs that have ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, or anticoagulants [see WARNINGS AND PRECAUTIONS].
- Caution patients about potential loss of effectiveness of drugs metabolized by CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptive agents) when Exjade is administered with these drugs [see DRUG INTERACTIONS].
- Caution patients about potential loss of effectiveness of Exjade when administered with drugs that are potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of Exjade when concomitantly used with potent UGT inducers [see DRUG INTERACTIONS].
- Caution patients about potential loss of effectiveness of Exjade when administered with drugs that are bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol). Based on serum ferritin levels and clinical response, consider increases in the dose of Exjade when concomitantly used with bile acid sequestrants [see DRUG INTERACTIONS].
- Perform careful monitoring of glucose levels when repaglinide is used concomitantly with Exjade. An interaction between Exjade and other CYP2C8 substrates like paclitaxel cannot be excluded [see DRUG INTERACTIONS].
- Advise patients that blood tests will be performed because Exjade may affect your kidneys, liver, or blood cells. The blood tests will be performed every month or more frequently if you are at increased risk of complications (e.g., preexisting kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your organs). There have been reports of severe kidney and liver problems, blood disorders, stomach hemorrhage and death in patients taking Exjade [see WARNINGS AND PRECAUTIONS].
- Skin rashes may occur during Exjade treatment and if severe, interrupt treatment. Serious allergic reactions (which include swelling of the throat) have been reported in patients taking Exjade, usually within the first month of treatment. If reactions are severe, advise patients to stop taking Exjade and contact their doctor immediately [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 8/21/2015
This monograph has been modified to include the generic and brand name in many instances.
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