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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
Prepared to a prescriber's order for one patient. Not FDA-approved.
Sirolimus is an mTOR inhibitor immunosuppressant that compounding pharmacies most often prepare as topical creams, ointments and gels for skin conditions.
Sirolimus, also called rapamycin, binds a protein inside cells called FKBP-12, and the pair blocks mTOR, a key enzyme that controls cell growth and immune cell activation. Manufactured sirolimus tablets and oral solution are FDA-approved to prevent organ rejection in kidney transplant recipients and to treat lymphangioleiomyomatosis (LAM), a rare lung disease. Hyftor (sirolimus topical gel, Nobelpharma) is approved for facial angiofibroma associated with tuberous sclerosis, and Fyarro, an albumin-bound injectable form, is approved for advanced malignant PEComa, a rare tumor. Dermatologists have used topical sirolimus off-label for other skin conditions, so a prescriber may order it compounded in a cream or ointment base, a different strength, or for an area the gel is not labeled for. Compounded preparations are not FDA-approved and require a prescription.
Oral sirolimus carries a boxed warning for immunosuppression, which raises the risk of serious infections, lymphoma and other cancers, and states it is not recommended in liver or lung transplant patients because of deaths, graft loss and airway healing problems. Other warnings include high cholesterol and triglycerides, slow wound healing, swelling, lung inflammation and kidney effects. Do not use it if you are allergic to sirolimus. Avoid grapefruit juice, and tell your prescriber about antifungals, certain antibiotics, rifampin and ACE inhibitors. Avoid live vaccines. Sirolimus can cause fetal harm; the oral labels recommend reliable birth control during treatment and for 12 weeks after. The Hyftor gel label notes it is absorbed through skin and does not recommend breastfeeding during treatment. LactMed says topical sirolimus is unlikely to affect a nursing infant if it is kept off the nipple area and the baby's skin does not touch treated skin; oral sirolimus should be used with caution while breastfeeding, especially with a newborn or preterm infant. Talk to your prescriber or pharmacist about irritation or signs of infection.
Sirolimus binds FKBP-12, and the complex inhibits mTOR. Per the oral label, systemic availability after oral solution is about 14%, plasma protein binding about 92% (mainly albumin), and mean terminal half-life about 62 hours in stable renal transplant patients. It is a substrate of CYP3A4 and P-gp; strong inhibitors such as voriconazole, itraconazole and clarithromycin are not recommended, and rifampin is a strong inducer. Labeled indications: oral tablets and solution for renal transplant prophylaxis and LAM; Hyftor gel for facial angiofibroma in tuberous sclerosis. After Hyftor application, sirolimus blood concentrations ranged from undetectable to very low with no evidence of accumulation. Prescribers have ordered compounded topical sirolimus for facial angiofibromas, port-wine stains (with pulsed-dye laser) and cutaneous vascular anomalies; a systematic review in Clinical and Experimental Dermatology describes this off-licence use and found localized irritation and pruritus the most common adverse effects. Dosing is per prescriber. For oral therapy, trough level monitoring is recommended for all patients, along with lipids, renal function and proteinuria. Sirolimus is not a controlled substance.
Wash your hands. Apply the amount on your label to clean, dry skin and rub it in gently. For a metered pump, each press delivers a set amount; your label states how many presses. For transdermal creams, apply to the area your label names and let it dry before dressing. Wash your hands afterward and avoid skin-to-skin contact with others at the application site until it has absorbed. Do not apply to broken skin unless told to.
Creams are aqueous. Under USP <795>, a preserved cream usually carries a beyond-use date of up to 35 days at room temperature or refrigerated, and an unpreserved one 14 days refrigerated. Follow the storage line on your label, keep from freezing, keep out of reach of children, and discard after the beyond-use date.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.
Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Apply topically to affected area(s)
