Posted on January 17, 2017 |
Answers provided by Gene Sullivan, MD, Emeritus Board Member of The LAM Foundation and former Deputy Director of the Division of Pulmonary and Allergy Products at the USFDA. Questions were created by The LAM Foundation by combining questions recently posed by patients with LAM.
My insurance requires that I use a generic form of sirolimus rather than the brand name drug, Rapamune. How do I know that generic form will work the same?
Generic products undergo rigorous FDA analysis prior to approval. FDA requires generic drugs to have the same quality and performance as brand named drugs. Per the FDA website:
- When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
- Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product.
- The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
- All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.
I heard that there was a recall of the Dr. Reddy product earlier this year. How do I know if my medication has been recalled? Do I need to worry if I took some of them?
The Dr. Reddy product was approved by the FDA as interchangeable with Rapamune before it was released as a generic alternative October 2014.
With regard to the July 2016 recall, any patient who was a part of the recall would have been contacted directly by their pharmacy. This recall only applied to certain lots of the product. See the below list of the lots and expiration dates. All affected lots were scheduled to expire on or before November, 2016.
The issue with the Dr. Reddy product involved detection of a trace amount of a breakdown product of sirolimus in the formulation, called secorarapamycin. A total of 9330 bottles of sirolimus were involved. The recall was classified as a Class III recall, which is used when the use of the product in question "is not likely to cause adverse health consequences.” Thus, the FDA ruling indicated that it is not likely that this minor impurity poses any risk to patients.
How do I know what is best for me – a generic or Rapamune?
There are many factors that may affect your decisions related to taking a generic or brand drug product. These may include insurance coverage, drug availability, cost, and personal choice. Sometimes this choice can be made without your knowledge, for example when an insurance company changes the drugs on their formulary.
You are your own best advocate when it comes to managing your care and your providing feedback to your caregivers about your treatment plan. It is very important that you pay attention to your prescription labels and that you develop a good relationship with your pharmacist.
Any changes to your prescription should be brought to the attention of both your pharmacist and your prescribing physician immediately. While it is unlikely that a change to or from a generic form of a drug will result in symptom changes, every patient has a unique response to drug therapy. Communication with your care team about how you are feeling is the best way to address your questions.
This recall only applied to certain lots of the product.