Sirolimus, albumin-bound
Brand names: Fyarro
Drug class:
Antineoplastic Agents
Usage of Sirolimus, albumin-bound
Perivascular Epithelioid Cell Tumor (PEComa)
Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Designated an orphan drug by FDA for this use.
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- Sirolimus, albumin-bound
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How to use Sirolimus, albumin-bound
General
Pretreatment Screening
Patient Monitoring
Dispensing and Administration Precautions
Administration
IV Administration
Administer by IV infusion.
ReconstitutionThe lyophilized powder must be reconstituted to an injectable suspension prior to IV infusion.
Using aseptic technique, inject 20 mL of 0.9% sodium chloride injection slowly (over a minimum period of 1 minute) into the vial containing the lyophilized powder. Direct the flow of diluent toward the inside wall of the vial rather than directly on the lyophilized cake to avoid foaming. After addition of diluent, allow vial to sit for a minimum of 5 minutes to ensure thorough wetting of the lyophilized cake/powder. Then, gently swirl and/or invert vial (do not shake) for at least 2 minutes until the cake/powder is completely dissolved; avoid foaming. If foaming or clumping occurs, allow the reconstituted suspension to stand for at least 15 minutes until foaming subsides. Do not use if foaming or clumping is present after 1 hour.
The reconstituted sirolimus suspension has a final concentration of 5 mg/mL.
Transfer the calculated volume of reconstituted albumin-bound sirolimus to an empty PVC or polyolefin infusion bag without further dilution.
Visually inspect reconstituted albumin-bound sirolimus suspension in the infusion bag prior to administration. Discard reconstituted suspension if particulate matter, proteinaceous strands, or discoloration are observed.
Rate of AdministrationAdminister IV infusion over 30 minutes.
Dosage
Dosage of albumin-bound sirolimus is expressed in terms of sirolimus.
Adults
Perivascular Epithelioid Cell Tumor (PEComa) in Adults IV100 mg/m2 as an IV infusion on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
Dosage Modifications for Adverse Reactions
Dosage interruption and/or reduction or discontinuance of therapy may be necessary based on severity of adverse reactions. See Table 1 for recommended dose reductions for adverse reactions and Table 2 for recommended dosage modifications/interventions for adverse effects.
Permanently discontinue albumin-bound sirolimus in patients who are unable to tolerate it after 3 dose reductions.
Table 1. Recommended Dosage Reductions of Albumin-bound Sirolimus for Adverse ReactionsDose Reduction
Dose
First dose reduction
75 mg/m2 (25% reduction from 100 mg/m2 )
Second dose reduction
56 mg/m2 (25% reduction from 75 mg/m2 )
Third dose reduction
45 mg/m2 (20% reduction from 56 mg/m2 )
Table 2. Recommended Albumin-bound Sirolimus Dosage Modifications for Adverse ReactionsAdverse Reaction
Dosage Modification
Stomatitis
Grade 2 or 3: Withhold until grade ≤1. Restart at the same dose for first occurrence. If recurs, restart at reduced dose level.
Grade 4: Permanently discontinue.
Anemia
Grade 2: Withhold until hemoglobin ≥8 g/dL. Restart at the same dose level.
Grade ≥3: Withhold until hemoglobin ≥8 g/dL. Restart at the same dose level. If recurs, resume at reduced dose level.
Thrombocytopenia
Grade 2: Withhold until platelet count >100,000/mm3. Restart at the same dose level.
Grade ≥3: Withhold until platelet count >100,000/mm3. Restart at reduced dose level.
Neutropenia
Grade 2 or 3: Withhold until absolute neutrophil count (ANC) ≥1500/mm3. Restart at the same dose level.
Grade 4: Withhold until ANC ≥1500/mm3. Restart at reduced dose level.
Infections
Grade 3: Withhold until infection is resolved, then restart at reduced dose level. If recurs, permanently discontinue.
Grade 4: Withhold until infection is resolved. Restart at reduced dose level or permanently discontinue.
Hypokalemia
Grade 2: Withhold until grade ≤1. Restart at the same dose level. If recurs, restart at reduced dose level.
Grade ≥3: Withhold until grade ≤1. Restart at reduced dose level. If recurs, permanently discontinue.
Hyperglycemia
Grade ≥3: Withhold until grade ≤2. Restart at reduced dose level.
Interstitial Lung Disease/Noninfectious Pneumonitis
Grade 2: Withhold for up to 3 weeks until grade ≤1, then restart at reduced dose level. If not resolved to Grade ≤1 within 3 weeks, permanently discontinue. If recurs, permanently discontinue.
Grade ≥3: Permanently discontinue.
Hemorrhage
Grade 2 or 3: Withhold until grade ≤1, then resume at reduced dose. If recurs, permanently discontinue.
Grade 4: Permanently discontinue.
Other Adverse Reactions
Grade 3: Withhold until grade ≤1, then restart at same dose level. If recurs, restart at reduced dose level.
Grade 4: Permanently discontinue.
Dosage Modification for Concomitant Use with CYP3A4 and/or P-gp Inhibitors and Inducers
Reduce initial dosage to 56 mg/m2 when used concomitantly with a moderate or weak cytochrome P-450 3A4 (CYP3A4) inhibitor.
Avoid concomitant use with strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitors and inducers and grapefruit and grapefruit juice.
Special Populations
Hepatic Impairment
Patients with mild (total bilirubin ≤ULN, AST >ULN or total bilirubin >1 to 1.5×ULN, any AST): reduce initial dosage to 75 mg/m2.
Patients with moderate hepatic impairment (total bilirubin >1.5 to 3×ULN, any AST): reduce initial dosage to 56 mg/m2.
Closely monitor patients with hepatic impairment for increased toxicity. Avoid use in patients with severe hepatic impairment.
Warnings
Contraindications
Warnings/Precautions
Stomatitis
Stomatitis, including mouth ulcers and oral mucositis, reported, most often within 8 weeks of treatment. Based on severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue.
Myelosuppression
Risk of myelosuppression including anemia, thrombocytopenia, and neutropenia.
Obtain blood counts at baseline and every 2 months for the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue.
Infections
Risk of infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections, and sinusitis reported.
Monitor patients for infections, including opportunistic infections. Based on severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue.
Hypokalemia
Risk of hypokalemia.
Monitor potassium levels prior to starting therapy and implement potassium supplementation as medically indicated. Based on severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue
Hyperglycemia
Risk of hyperglycemia.
Monitor fasting serum glucose prior to starting albumin-bound sirolimus. During treatment, monitor serum glucose every 3 months in nondiabetic patients, or as clinically indicated. Monitor serum glucose more frequently in diabetic patients. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue.
Interstitial Lung Disease/Non-infectious Pneumonitis
Risk of interstitial lung disease (ILD)/non-infectious pneumonitis. Based on severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue.
Hemorrhage
Risk of serious and sometimes fatal hemorrhage.
Monitor patients for signs and symptoms of hemorrhage. Based on severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue.
Hypersensitivity Reactions
Possible hypersensitivity reactions.
Hypersensitivity reactions, including anaphylactic, angioedema, exfoliative dermatitis and hypersensitivity vasculitis, reported with oral sirolimus.
Hypersensitivity reactions including anaphylaxis also observed with human albumin.
Monitor patients closely for signs and symptoms of infusion reactions during and following each infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Monitor patients for at least 2 hours after the first infusion and as clinically needed for each subsequent infusion.
Reduce the rate, interrupt infusion, or permanently discontinue based on severity and institute appropriate medical management as needed.
Embryofetal Toxicity
Based on animal studies and the mechanism of action, can cause fetal harm when administered to a pregnant woman. In animal studies, oral sirolimus was embryo/fetotoxic in rats at sub-therapeutic doses. (See Pregnancy under Cautions.)
Male Infertility
Azoospermia or oligospermia may be observed in patients treated with albumin-bound sirolimus.
Immunizations and Risks Associated with Live Vaccines
No studies in conjunction with immunization have been conducted. Immunization during treatment may be ineffective.
Update immunizations according to immunization guidelines prior to initiating treatment, if possible. Immunization with live vaccines is not recommended during treatment and avoid close contact with those who have received live vaccines while receiving treatment. The interval between live vaccinations and initiation of albumin-bound sirolimus should be in accordance with current vaccination guidelines for patients on immunosuppressive therapies.
Risk of Transmission of Infectious Agents with Human Albumin
Contains human albumin, a derivative of human blood. Human albumin carries only a remote risk of transmission of viral diseases because of effective donor screening and product manufacturing processes. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote.
No cases of transmission of viral diseases or CJD have ever been associated with albumin.
Specific Populations
PregnancyMay cause fetal harm based on animal studies and mechanism of action. Limited data on use of sirolimus during pregnancy. Advise pregnant women of the potential risk to a fetus. (See Females and Males of Reproductive Potential under Cautions.)
LactationNo data exist on presence of albumin-bound sirolimus in human milk or its effects on the breastfed child or on milk production.
Sirolimus is present in the milk of lactating rats. There is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action.
Advise women not to breastfeed during treatment with albumin-bound sirolimus and for 2 weeks after the last dose.
Females and Males of Reproductive PotentialVerify pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with albumin-bound sirolimus and for 12 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with albumin-bound sirolimus and for 12 weeks after the last dose.
Male and female fertility may be compromised by treatment with albumin-bound sirolimus. Ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) reported in females receiving oral sirolimus. Azoospermia, which has been reversible upon discontinuation in most cases, reported in males receiving oral sirolimus.
Pediatric UseSafety and efficacy in pediatric patients not established.
Geriatric UseClinical studies of albumin-bound sirolimus did not include sufficient numbers of patients 65 years of age and over to determine whether they respond differently from younger patients.
Hepatic ImpairmentNot recommended in patients with severe hepatic impairment. Reduce dosage in patients with mild or moderate hepatic impairment.
Common Adverse Effects
Common adverse effects (≥30%): stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, dysgeusia.
Common grade 3 to 4 laboratory abnormalities (≥6%): decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, increased lipase.
What other drugs will affect Sirolimus, albumin-bound
Metabolized by CYP isoenzymes, principally CYP3A; substrate of both CYP3A4 and P-gp.
Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes
Strong CYP3A4 Inhibitors or Inducers: Avoid concomitant use.
Moderate or Weak CYP3A4 Inhibitors: Use of albumin-bound sirolimus with moderate or weak CYP3A4 inhibitors may result in increased levels of sirolimus. Reduce dosage of albumin-bound sirolimus when used concomitantly with a moderate or weak CYP3A4 inhibitor.
Moderate or Weak CYP3A4 Inducers: Use of albumin-bound sirolimus with moderate or weak CYP3A4 inducers may result in decreased effectiveness.
Drugs Affecting or Affected by Transport Proteins
P-gp Inhibitors or Inducers: Avoid concomitant use of albumin-bound sirolimus with P-gp inhibitors or inducers.
Specific Drugs
Drug or Food
Interaction
Comments
Grapefruit or grapefruit juice
Potential increased sirolimus concentrations
Avoid use
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- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions