"The US Food and Drug Administration (FDA) has approved calcifediol (Rayaldee, Opko Health, Inc) for the treatment of adults with secondary hyperparathyroidism (SHPT) associated with vitamin D insufficiency (serum total 25-hydroxyvitamin D "...
Patients should be informed of the following information to aid in the safe and effective use of TIROSINT:
Dosing and Administration
- Instruct patients that TIROSINT should only be taken as directed by their healthcare provider.
- Instruct patients to take TIROSINT one-half to one hour before breakfast.
- Instruct patients that TIROSINT capsules should never be crushed or cut.
- Instruct patients to notify their healthcare provider should they become pregnant or are thinking of becoming pregnant while taking TIROSINT. It is likely that the dose of TIROSINT will need to be increased during pregnancy.
- To assist with identifying the name and strength of each Tirosint capsule, instruct patients not to remove capsules from the blisters in advance, particularly if they are taking multiple strengths.
- Inform patients that it may take several weeks before they notice an improvement in symptoms.
- Inform patients that the levothyroxine in TIROSINT is intended to replace a hormone that is normally produced by the thyroid gland. Generally, replacement therapy is to be taken for life.
- Inform patients that TIROSINT should not be used as a primary or adjunctive therapy in a weight control program.
- Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations.
- Instruct patients to notify their healthcare provider of any other medical conditions, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these oth>er conditions may need to be adjusted while taking TIROSINT. If patients are taking anticoagulants (blood thinners), their clotting status should be checked frequently.
- Instruct patients to notify their healthcare provider if they experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event.
- Inform patients that partial hair loss may occur rarely during the first few months of TIROSINT therapy; this is usually temporary.
Last reviewed on RxList: 10/27/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Tirosint Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.