If you’ve ever taken an oral bisphosphonate, you know what a hassle it is. You have to take them on an empty stomach, with eight ounces of water only; stay upright for 30-60 minutes afterwards, and remember to take it on a daily, weekly, bi-monthly or monthly schedule. Because of all these restrictions and the many side effects, some patients have, the adherence rate on this treatment is very low.
The manufacturer of Risedronate (Actonel ®), has just received FDA approval for a time-released version of their osteoporosis medication. This new form of Risedronate is called AtelviaTM, and it can be taken immediately after you’ve eaten a meal with four ounces of water. You must remain upright for 30 minutes after taking Atelvia, just like you would if taking Actonel.
This new formulation may help with those who have trouble with compliance, since it eliminates one of the major obstacles in its dosing. However, this new formulation is only available in the once weekly dose of 35 milligrams.
This new drug is approved for post menopausal women with osteoporosis and not for other metabolic bone diseases, like Paget’s disease, men with osteoporosis or glucocorticoid induced osteoporosis, as is Actonel.
Warnings and Precautions:
Atelvia and Actonel contain the same active ingredient. Patients receiving Actonel should not be treated with Atelvia.
- Severe irritation of the upper gastrointestinal (GI) mucosa can occur._ Dosing instructions should be followed and caution should be used in_ patients with active upper GI disease. Discontinue use if new or worsening symptoms occur.
- Hypocalcemia may worsen and must be corrected prior to use.
- Osteonecrosis of the jaw has been reported rarely.
- Severe bone, joint, or muscle pain may occur. Consider discontinuing use if severe symptoms develop (Atelvia Prescribing Information, Warner Chilcott 2010).
Most common adverse reactions (>5%) include: diarrhea, influenza, arthralgia, back pain, and abdominal pain. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely (Atelvia Prescribing Information, Warner Chilcott 2010).
If you have severe renal impairment (creatinine clearance of <30 mL/min), Atelvia is not recommended.
Atelvia has not been approved for use in pediatric patients.
Calcium and vitamin D supplement should be spaced out from the Atelvia dosing, since taking these with the medication can cause a 38% reduction in Atelvia absorption. Also, antacids, iron, magnesium based laxatives or supplements should not be administered at the same time as Atelvia due to the decrease in possible absorption.
The FDA included Atelvia in its, October 13, 2010 warning on bisphosphonates and atypical femur fractures. For more information about these femur fractures caused by bisphosphonates, see this article on subtrochanteric femur fractures.
The half life of Atelvia, in post menopausal women, was 561 hours.
This new formulation will be available in early 2011. We’ll have to wait and see what the retail price will be and which insurance carriers will cover it.
Atelvia Prescribing Information, Warner Chilcott, Oct. 2010
FDA Warning and Label Change on all Bisphosphonates, Oct. 13, 2010