Sirolimus 0.01% Cream

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This prescription has been compounded by Physicians Preference Pharmacy on physician’s orders.

MEDICATION: Phys Pref Sirolimus capsules contain the active ingredient sirolimus. Sirolimus taken on a daily dosing schedule is indicated as an immunosuppressive agent in transplant recipients, but at a lower dosing frequency, acts as an mTOR inhibitor which may improve lifespan and “health span”. Phys Pref Sirolimus may offer benefits such as improved strength and endurance, increased energy, increased testosterone levels, decreased LDL levels, decreased inflammation, protection against cognitive decline, improved cardiovascular function, reduced gut dysbiosis, improved sleep, reduced blood pressure, noticeably improved skin health, and weight loss.

WARNING: Do not take if you are pregnant or breastfeeding or intend to become pregnant or breastfeeding.

Using sirolimus with other medications: Sirolimus may interact with other substances, affecting the blood levels of sirolimus. ie: Grapefruit juice may increase sirolimus levels, while medications such as phenobarbital may decrease them. Talk to your prescriber about any other medications you are taking before starting sirolimus and inform your pharmacist. Talk to your pharmacist about potential drug-drug interactions.

Immunosuppression

Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression.^Ref

Experienced health care providers

Only health care providers experienced in immunosuppressive therapy and management of renal transplant patients should use sirolimus for prophylaxis of organ rejection in patients receiving renal transplants. Patients receiving sirolimus should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.^Ref

Liver transplantation

The use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death. In this and another study in de novo liver transplant patients, the use of sirolimus in combination with cyclosporine or tacrolimus was associated with an increase in hepatic artery thrombosis; most cases of hepatic artery thrombosis occurred within 30 days posttransplantation, and most led to graft loss or death. The safety and efficacy of sirolimus as immunosuppressive therapy have not been established in liver transplant patients; therefore, such use is not recommended.^Ref

Lung transplantation

Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen. The safety and efficacy of sirolimus as immunosuppressive therapy have not been established in lung transplant patients; therefore, such use is not recommended.^Ref

SIDE EFFECTS: Side effects of sirolimus may include nausea and possible mouth ulcers, although these effects typically occur with higher dosing.

DIRECTIONS: Take as directed by your provider.

MISSED DOSAGE: If you miss your dose, take it as soon as you remember. If you forget completely, do not “double-up” the dose the next day or within the same week.

STORAGE: Upon receipt, store at controlled room temperature away from sunlight and moisture.

DESCRIPTION: White powder in a dye free capsule, white cream, topical liquid.

DISPOSAL OF UNUSED MEDICATION: Do not flush unused medication or pour down sink or drain.

Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at 281-828-9088 or 877-640-5248.

Complaints against the practice of pharmacy may be filed with the Texas State

Board of Pharmacy/1801 Congress Avenue, Ste 13.100/Austin, TX 78701/(512)