For which conditions is Reclast approved for? Reclast is FDA approved for the treatment and prevention of postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, and to treat and prevent glucocorticoid-induced osteoporosis. People with rheumatoid arthritis (RA) may be at increased risk for osteoporosis, in part because glucocorticoids are often used in their treatment. Rheumatoid arthritis itself might also cause bone loss. In addition, people who are in pain and have reduced joint function due to RA might be less active, which increases risk of bone loss. (Reclast is also approved to treat Paget’s disease, a condition that causes rapid isolated bone repair and a variety of symptoms—from softer bones to enlarged bone growth.)
What is the mechanism of action? Reclast is a type of drug known as a bisphosphonate. Bisphosphonates reduce bone loss by inhibiting osteoclasts (cells that break down bone).
How is Reclast typically given (administered)? Reclast is given intravenously (into a vein). The frequency of administration depends on the purpose of treatment. For the treatment of osteoporosis, Reclast is generally given once per year.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Reclast. Patients may undergo blood tests, physical examinations, scans, or other measures to assess side effects and response to therapy.
What serious side effects can occur with Reclast?
- Low calcium levels in the blood
- Severe kidney problems
- Severe jaw bone problems (osteonecrosis of the jaw)
- Bone, joint, or muscle pain
- Unusual fractures of the femur (the thigh bone)
What are the most common side effects of treatment with Reclast?
- Pain in bones, joints, or muscles
- Pain in arms or legs
- Flu-like illness
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain proper oral hygiene and care.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, pain relievers, antibiotics, diuretics, etc.), as they may interact with treatment.
- Patients should inform their physician if they are pregnant, breastfeeding, or planning a family in the near future.
- Patients should inform their physician about all medical conditions, including kidney problems, low blood calcium, previous thyroid or parathyroid surgery, problems absorbing minerals, and allergies.
- Patients should inform their doctor about any upcoming dental surgery or tooth extractions.
- Patients may need to undergo an oral examination prior to starting treatment with Reclast.
When should patients notify their physician?
Tell your doctor if you experience any unusual symptoms. Notify your healthcare provider immediately if you experience symptoms of hypocalcemia (low calcium levels), such as muscle spasms, twitches, or cramps, or numbness or tingling in fingers, toes, or the area around your mouth. You should also notify your doctor if you experience symptoms of a fracture or severe bone, joint, or muscle pain. Because Reclast should not be used if you are pregnant, inform your doctor if you become pregnant or plan to become pregnant.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.