sirolimus (topical)

section name header

Pronunciation ⬇

sir-OH-li-mus

Classifications ⬆ ⬇

Therapeutic Classification: Immunosuppressant agents

Indications ⬆ ⬇

High Alert

Facial angiofibroma associated with tuberous sclerosis.

Action ⬆ ⬇

Inhibits mammalian target of rapamycin activation. Mechanism in treatment of angiofibroma associated with tuberous sclerosis unknown.

Therapeutic effects:

Reduction in size and redness of facial angiofibroma.

Pharmacokinetics ⬆ ⬇

Absorption: Minimally absorbed into systemic circulation.

Distribution: Not distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
Topical	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Children <6 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: acne, dry skin, pruritus, dermatitis

EENT: eye irritation, ocular hyperemia

GU: amenorrhea, infertility (men), menorrhagia, ovarian cysts

Local: application site irritation

Metab: hypercholesterolemia, hypertriglyceridemia

Neuro: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Resp: interstitial lung disease (ILD)

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION , MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

CYP3A4 inhibitors may ↑ levels and risk of toxicity.
May ↑ levels and risk of toxicity of CYP3A4 substrates and CYP3A4 inhibitors.
Concurrent use with ACE inhibitors may ↑ risk of angioedema.
Vaccines may be less effective if given concurrently with sirolimus; avoid use of live-virus vaccines.

Route/Dosage ⬆ ⬇

(Adults and Children ≥12 yr): Apply twice daily (in the AM and at bedtime) to affected facial area(s) (max daily dose = 800 mg [2.5 cm]). If symptoms do not improve within 12 wk, re-evaluate need for continuing therapy.
(Children 6–11 yr): Apply twice daily (in the AM and at bedtime) to affected facial area(s) (max daily dose = 600 mg [2 cm]). If symptoms do not improve within 12 wk, re-evaluate need for continuing therapy.

Availability ⬆ ⬇

Topical gel: 0.2%

Assessment ⬆ ⬇

Assess for hypersensitivity reaction, serious infection including PML, ILD, and lymphoma as clinically indicated during therapy. These pathologies are associated with oral sirolimus. Sirolimus topical should be discontinued if these pathologies occur.

Lab Test Considerations:

Monitor serum cholesterol and triglycerides during therapy.

Implementation ⬆ ⬇

High Alert: Do not confuse sirolimus with silodosin.
All age-appropriate vaccinations should be completed per current guidelines prior to initiation.
Topical Apply colorless, transparent gel topically. Not for oral, ophthalmic, or intravaginal use. Do not use with occlusive dressing. Use gloves and wash hands thoroughly after application.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to wash hands thoroughly after application and to not cover the skin being treated with a bandage or wrap.
Advise patient to discontinue sirolimus and notify health care professional immediately for symptoms of hypersensitivity (rash, exfoliative dermatitis, angioedema), difficulty breathing, or serious infection.
Advise patient to minimize or avoid exposure to natural or artificial sunlight with protective clothing.
Inform patient to avoid live vaccines during therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Women of reproductive potential should use effective contraception during and for 12 wk after last dose, and avoid breastfeeding. Notify health care professional if pregnancy is planned or suspected or if breastfeeding. May cause female and male infertility.

Evaluation/Desired Outcomes ⬆ ⬇

↓size and redness of facial angiofibroma.

US Brand Names ⬆ ⬇

Hyftor

Code ⬆

NDC Code

0008- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- 0008-1041- Rapamune
  - 0008-1041-05- 100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1041-05)

0008- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- 0008-1042- Rapamune
  - 0008-1042-05- 100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1042-05)

0904- Major Pharmaceuticals
- 0904-7248- Sirolimus
  - 0904-7248-04- 30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET in 1 BLISTER PACK

16571- Rising Pharma Holdings, Inc.
- 16571-806- Sirolimus
  - 16571-806-06- 1 CARTON in 1 KIT (16571-806-06) / 1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS

16714- NORTHSTAR RX LLC
- 16714-187- sirolimus
  - 16714-187-01- 100 TABLET, FILM COATED in 1 BOTTLE (16714-187-01)

16714- NORTHSTAR RX LLC
- 16714-188- sirolimus
  - 16714-188-01- 100 TABLET, FILM COATED in 1 BOTTLE (16714-188-01)

16714- NORTHSTAR RX LLC
- 16714-189- sirolimus
  - 16714-189-01- 100 TABLET, FILM COATED in 1 BOTTLE (16714-189-01)

31722- Camber Pharmaceuticals, Inc.
- 31722-316- SIROLIMUS
  - 31722-316-31- 1 CARTON in 1 KIT (31722-316-31) / 1 BOTTLE, GLASS in 1 CARTON (31722-316-60) / 60 mL in 1 BOTTLE, GLASS

42513- Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
- 42513-0013-
  - 42513-0013-1- 1 BAG in 1 CARTON (42513-0013-1) / 1 BOTTLE in 1 BAG / 1 BAG in 1 BOTTLE / 1 kg in 1 BAG

42513- Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
- 42513-0013-
  - 42513-0013-2- 1 BAG in 1 CARTON (42513-0013-2) / 1 BOTTLE in 1 BAG / 1 BAG in 1 BOTTLE / 3 kg in 1 BAG

42513- Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
- 42513-0013-
  - 42513-0013-3- 2 BAG in 1 CARTON (42513-0013-3) / 1 BOTTLE in 1 BAG / 1 BAG in 1 BOTTLE / 3 kg in 1 BAG

42816- Pfizer Ireland Pharmaceuticals Unlimited Company
- 42816-1040-
  42816-1040-1- 1 BAG in 1 DRUM (42816-1040-1) / 33588 TABLET, SUGAR COATED in 1 BAG

42816- Pfizer Ireland Pharmaceuticals Unlimited Company
- 42816-1041-
  42816-1041-1- 1 BAG in 1 DRUM (42816-1041-1) / 33588 TABLET, SUGAR COATED in 1 BAG

42816- Pfizer Ireland Pharmaceuticals Unlimited Company
- 42816-1042-
  42816-1042-1- 1 BAG in 1 DRUM (42816-1042-1) / 33588 TABLET, SUGAR COATED in 1 BAG

50268- AvPAK
- 50268-718- Sirolimus
  50268-718-13- 30 BLISTER PACK in 1 BOX (50268-718-13) / 1 TABLET in 1 BLISTER PACK (50268-718-11)

51187- Hisun Pharmaceutical (Hangzhou) Co., Ltd.
- 51187-0010-
  - 51187-0010-1- .5 kg in 1 DRUM (51187-0010-1)

51187- Hisun Pharmaceutical (Hangzhou) Co., Ltd.
- 51187-0010-
  51187-0010-2- 2 kg in 1 DRUM (51187-0010-2)

55111- Dr. Reddy's Laboratories Limited
- 55111-653- Sirolimus
  55111-653-01- 100 TABLET in 1 BOTTLE (55111-653-01)

55111- Dr. Reddy's Laboratories Limited
- 55111-653- Sirolimus
  - 55111-653-30- 30 TABLET in 1 BOTTLE (55111-653-30)

55111- Dr. Reddy's Laboratories Limited
- 55111-654- Sirolimus
  - 55111-654-01- 100 TABLET in 1 BOTTLE (55111-654-01)

55111- Dr. Reddy's Laboratories Limited
- 55111-654- Sirolimus
  - 55111-654-30- 30 TABLET in 1 BOTTLE (55111-654-30)

55486- Curia Italy S.r.l.
- 55486-1571-
  - 55486-1571-0- 4 kg in 1 DRUM (55486-1571-0)

55500- North China Pharmaceutical Huasheng Co. Ltd.
- 55500-0011-
  55500-0011-1- 1 kg in 1 CARTON (55500-0011-1)

55500- North China Pharmaceutical Huasheng Co. Ltd.
- 55500-0011-
  55500-0011-2- 1 kg in 1 CARTON (55500-0011-2)

56125- Novo Nordisk Production Ireland Limited
- 56125-800-
  56125-800-01- 66.7 kg in 1 CAN (56125-800-01)

57885- Chongqing Daxin Pharmaceutical Co. Ltd.
- 57885-0014-
  57885-0014-2- 10 kg in 1 BAG (57885-0014-2)

59573- Fujian Kerui Pharmaceutical Co., Ltd.
- 59573-0004-
  59573-0004-1- 500 g in 1 BAG (59573-0004-1)

59762- Mylan Pharmaceuticals Inc.
- 59762-1001- Sirolimus
  59762-1001-1- 100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1001-1)

59762- Mylan Pharmaceuticals Inc.
- 59762-1002- Sirolimus
  - 59762-1002-1- 100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1002-1)

59762- Mylan Pharmaceuticals Inc.
- 59762-1003- Sirolimus
  - 59762-1003-1- 100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1003-1)

59762- Mylan Pharmaceuticals Inc.
- 59762-1205- Sirolimus
  - 59762-1205-6- 1 CARTON in 1 KIT (59762-1205-6) / 1 BOTTLE, GLASS in 1 CARTON (59762-1205-4) / 60 mL in 1 BOTTLE, GLASS

60505- Apotex Corp
- 60505-6197- Sirolimus
  - 60505-6197-2- 1 BOTTLE, GLASS in 1 CARTON (60505-6197-2) / 60 mL in 1 BOTTLE, GLASS

62991- LETCO MEDICAL, LLC
- 62991-3184-
  - 62991-3184-1- 1 g in 1 JAR (62991-3184-1)

62991- LETCO MEDICAL, LLC
- 62991-3184-
  62991-3184-2- 5 g in 1 JAR (62991-3184-2)

65727- Biocon Limited
- 65727-013-
  65727-013-01- 25 kg in 1 DRUM (65727-013-01)

65841- Zydus Lifesciences Limited
- 65841-771- sirolimus
  65841-771-01- 100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01)

65841- Zydus Lifesciences Limited
- 65841-771- sirolimus
  - 65841-771-05- 500 TABLET, FILM COATED in 1 BOTTLE (65841-771-05)

65841- Zydus Lifesciences Limited
- 65841-771- sirolimus
  - 65841-771-06- 30 TABLET, FILM COATED in 1 BOTTLE (65841-771-06)

65841- Zydus Lifesciences Limited
- 65841-771- sirolimus
  - 65841-771-10- 1000 TABLET, FILM COATED in 1 BOTTLE (65841-771-10)

65841- Zydus Lifesciences Limited
- 65841-771- sirolimus
  - 65841-771-16- 90 TABLET, FILM COATED in 1 BOTTLE (65841-771-16)

65841- Zydus Lifesciences Limited
- 65841-771- sirolimus
  - 65841-771-77- 10 BLISTER PACK in 1 CARTON (65841-771-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-771-30)

65841- Zydus Lifesciences Limited
- 65841-772- sirolimus
  - 65841-772-01- 100 TABLET, FILM COATED in 1 BOTTLE (65841-772-01)

65841- Zydus Lifesciences Limited
- 65841-772- sirolimus
  - 65841-772-77- 10 BLISTER PACK in 1 CARTON (65841-772-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-772-30)

65841- Zydus Lifesciences Limited
- 65841-773- sirolimus
  - 65841-773-01- 100 TABLET, FILM COATED in 1 BOTTLE (65841-773-01)

65841- Zydus Lifesciences Limited
- 65841-773- sirolimus
  - 65841-773-77- 10 BLISTER PACK in 1 CARTON (65841-773-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-773-30)

66689- VistaPharm, LLC
- 66689-347- Sirolimus
  - 66689-347-02- 1 CARTON in 1 KIT (66689-347-02) / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

67877- Ascend Laboratories, LLC
- 67877-746- Sirolimus
  - 67877-746-01- 100 TABLET in 1 BOTTLE (67877-746-01)

67877- Ascend Laboratories, LLC
- 67877-746- Sirolimus
  - 67877-746-05- 500 TABLET in 1 BOTTLE (67877-746-05)

67877- Ascend Laboratories, LLC
- 67877-746- Sirolimus
  - 67877-746-30- 30 TABLET in 1 BOTTLE (67877-746-30)

67877- Ascend Laboratories, LLC
- 67877-746- Sirolimus
  - 67877-746-38- 100 BLISTER PACK in 1 CARTON (67877-746-38) / 10 TABLET in 1 BLISTER PACK (67877-746-33)

67877- Ascend Laboratories, LLC
- 67877-747- Sirolimus
  - 67877-747-01- 100 TABLET in 1 BOTTLE (67877-747-01)

67877- Ascend Laboratories, LLC
- 67877-747- Sirolimus
  - 67877-747-05- 500 TABLET in 1 BOTTLE (67877-747-05)

67877- Ascend Laboratories, LLC
- 67877-747- Sirolimus
  - 67877-747-30- 30 TABLET in 1 BOTTLE (67877-747-30)

67877- Ascend Laboratories, LLC
- 67877-747- Sirolimus
  - 67877-747-38- 100 BLISTER PACK in 1 CARTON (67877-747-38) / 10 TABLET in 1 BLISTER PACK (67877-747-33)

67877- Ascend Laboratories, LLC
- 67877-748- Sirolimus
  - 67877-748-01- 100 TABLET in 1 BOTTLE (67877-748-01)

67877- Ascend Laboratories, LLC
- 67877-748- Sirolimus
  - 67877-748-05- 500 TABLET in 1 BOTTLE (67877-748-05)

67877- Ascend Laboratories, LLC
- 67877-748- Sirolimus
  - 67877-748-30- 30 TABLET in 1 BOTTLE (67877-748-30)

67877- Ascend Laboratories, LLC
- 67877-748- Sirolimus
  - 67877-748-38- 100 BLISTER PACK in 1 CARTON (67877-748-38) / 10 TABLET in 1 BLISTER PACK (67877-748-33)

68084- American Health Packaging
- 68084-915- Sirolimus
  - 68084-915-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-915-25) / 1 TABLET in 1 BLISTER PACK (68084-915-95)

68254- CONCORD BIOTECH LTD
- 68254-1006-
  - 68254-1006-2- 1 BAG in 1 BOTTLE (68254-1006-2) / 1 kg in 1 BAG

68382- Zydus Pharmaceuticals USA Inc.
- 68382-351- sirolimus
  68382-351-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-351-01)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-351- sirolimus
  - 68382-351-77- 10 BLISTER PACK in 1 CARTON (68382-351-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-351-30)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-352- sirolimus
  - 68382-352-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-352-01)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-352- sirolimus
  - 68382-352-77- 10 BLISTER PACK in 1 CARTON (68382-352-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-352-30)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-520- sirolimus
  - 68382-520-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-520-01)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-520- sirolimus
  - 68382-520-05- 500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-520- sirolimus
  - 68382-520-06- 30 TABLET, FILM COATED in 1 BOTTLE (68382-520-06)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-520- sirolimus
  - 68382-520-10- 1000 TABLET, FILM COATED in 1 BOTTLE (68382-520-10)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-520- sirolimus
  - 68382-520-16- 90 TABLET, FILM COATED in 1 BOTTLE (68382-520-16)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-520- sirolimus
  - 68382-520-77- 10 BLISTER PACK in 1 CARTON (68382-520-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-520-30)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-682- sirolimus
  - 68462-682-01- 100 TABLET, FILM COATED in 1 BOTTLE (68462-682-01)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-683- sirolimus
  - 68462-683-01- 100 TABLET, FILM COATED in 1 BOTTLE (68462-683-01)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-684- sirolimus
  - 68462-684-01- 100 TABLET, FILM COATED in 1 BOTTLE (68462-684-01)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1594- Sirolimus
  - 69238-1594-3- 1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS

70518- REMEDYREPACK INC.
- 70518-3546- Sirolimus
  - 70518-3546-0- 100 POUCH in 1 BOX (70518-3546-0) / 1 TABLET in 1 POUCH (70518-3546-1)

70518- REMEDYREPACK INC.
- 70518-4376- sirolimus
  - 70518-4376-0- 100 POUCH in 1 BOX (70518-4376-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4376-1)

70518- REMEDYREPACK INC.
- 70518-4449- sirolimus
  - 70518-4449-0- 100 POUCH in 1 BOX (70518-4449-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4449-1)

71052- Darmerica, LLC
- 71052-202-
  - 71052-202-01- .001 kg in 1 BOTTLE (71052-202-01)

71052- Darmerica, LLC
- 71052-202-
  71052-202-05- .005 kg in 1 BOTTLE (71052-202-05)

71052- Darmerica, LLC
- 71052-202-
  71052-202-10- .01 kg in 1 PACKAGE (71052-202-10)

71052- Darmerica, LLC
- 71052-202-
  71052-202-25- .025 kg in 1 CONTAINER (71052-202-25)

72205- Novadoz Pharmaceuticals LLC
- 72205-099- sirolimus
  72205-099-78- 1 BOTTLE, GLASS in 1 CARTON (72205-099-78) / 60 mL in 1 BOTTLE, GLASS

73212- Qingdao Biopeptek Co., Ltd.
- 73212-019-
  - 73212-019-01- 1 g in 1 BOTTLE (73212-019-01)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-019-
  73212-019-05- 5 g in 1 BOTTLE (73212-019-05)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-019-
  73212-019-10- 10 g in 1 BOTTLE (73212-019-10)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-019-
  73212-019-11- 50 g in 1 BOTTLE (73212-019-11)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-019-
  73212-019-12- 100 g in 1 BOTTLE (73212-019-12)

73377- AX Pharmaceutical Corp
- 73377-024-
  73377-024-01- 10 g in 1 JAR (73377-024-01)

73377- AX Pharmaceutical Corp
- 73377-024-
  73377-024-02- 1 g in 1 JAR (73377-024-02)

73377- AX Pharmaceutical Corp
- 73377-024-
  73377-024-03- 100 g in 1 JAR (73377-024-03)

73377- AX Pharmaceutical Corp
- 73377-024-
  73377-024-04- 50 g in 1 JAR (73377-024-04)

73377- AX Pharmaceutical Corp
- 73377-024-
  73377-024-05- 5 g in 1 JAR (73377-024-05)

73377- AX Pharmaceutical Corp
- 73377-024-
  73377-024-06- 1.6 g in 1 JAR (73377-024-06)

73377- AX Pharmaceutical Corp
- 73377-024-
  73377-024-07- .5 g in 1 JAR (73377-024-07)

73683- Nobelpharma America, LLC
- 73683-101- HYFTOR
  73683-101-10- 1 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE

80803- Aadi Bioscience
- 80803-153- FYARRO
  - 80803-153-50- 1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE

82393- Pharma Source Direct, Inc.
- 82393-501-
  - 82393-501-04- .001 kg in 1 CONTAINER (82393-501-04)

82393- Pharma Source Direct, Inc.
- 82393-501-
  82393-501-05- .005 kg in 1 CONTAINER (82393-501-05)

82393- Pharma Source Direct, Inc.
- 82393-501-
  82393-501-07- .025 kg in 1 CONTAINER (82393-501-07)

82393- Pharma Source Direct, Inc.
- 82393-501-
  82393-501-08- .1 kg in 1 CONTAINER (82393-501-08)

84517- Zhejiang Wild Wind Pharmaceutical Co.,Ltd.
- 84517-032-
  84517-032-01- 1 kg in 1 BAG (84517-032-01)