Interactions between Omacetaxine and Sirolimus
1 drug interaction and 14 additional warnings found for the following 2 drugs:
- omacetaxine
- sirolimus
Drug interactions
Moderate drug interactions
Moderate:
sirolimus omacetaxine
Applies to: sirolimus and omacetaxine
Monitor
The use of omacetaxine with other immunosuppressive or myelosuppressive agents may increase the risk of infections. Omacetaxine alone may cause severe myelosuppression, neutropenia, lymphopenia, and opportunistic infections. In clinical trials, infections/infestations (bacterial, viral, fungal, and nonspecified) were reported in up to 56% of patients, and grade 3 or 4 infections/infestations in up to 20% of patients. The risk may theoretically increase when coadministered with other hematotoxic therapy. Agents that may be significantly myelo- or immunosuppressive include antineoplastic agents, radiation, zidovudine, linezolid, some antirheumatic agents, high dosages of corticosteroids or adrenocorticotropic agents (greater than 10 mg/day to 1 mg/kg/day, whichever is less, of prednisone or equivalent for more than 2 weeks), and long-term topical or inhaled corticosteroids.
Management
Caution is advised if omacetaxine must be used in patients who have recently received or are receiving treatment with other immunosuppressive or myelosuppressive drugs, and vice versa. Close clinical and laboratory monitoring for the development of severe hematologic adverse effects is recommended both during and after discontinuation of therapy. Patients should be advised to seek medical attention if they experience symptoms such as fever, chills, shortness of breath, fatigue, and any unusual bleeding or bruising.
References (1)
- (2012) "Product Information. Synribo (omacetaxine)." Teva Pharmaceuticals USA
Food/lifestyle interactions
Moderate food/lifestyle interactions
Moderate:
sirolimus Food/Lifestyle
Applies to: sirolimus
Adjust dosing interval
Consumption of food can decrease the rate and extent of gastrointestinal absorption of sirolimus. Also, the consumption of grapefruit juice may result in increased sirolimus trough concentrations.
Management
Experts recommend that this drug be taken either at least one hour prior to eating or consistently with or without food to avoid variations in sirolimus blood levels. The manufacturer recommends against using grapefruit juice for dilution of sirolimus doses. Patients should be monitored for clinical and laboratory evidence of altered immunosuppressant effects.
References (1)
- (2001) "Product Information. Rapamune (sirolimus)." Wyeth-Ayerst Laboratories
Disease interactions
13 potential interactions Applies to: 12 conditions, including High Cholesterol, Diabetes Mellitus, Liver Disease, Infection, and Bleeding Disorder.
Angioedema
Moderate:
sirolimus
Sirolimus has a moderate potential interaction with Angioedema.
Sirolimus has been associated with the development of angioedema. Patients at risk of developing angioedema and those using concomitant drugs known to cause angioedema, such as ACE inhibitors, may be at increased risk of developing angioedema. Care should be taken when prescribing this agent in patients at risk and close monitoring is recommended.
Bleeding Disorder
Moderate:
omacetaxine
Omacetaxine has a moderate potential interaction with Bleeding Disorder.
Omacetaxine can cause severe thrombocytopenia. Bleeding events, including fatalities from cerebral hemorrhage, and severe, non-fatal, gastrointestinal hemorrhages have been reported in clinical trials. Perform complete blood counts, including platelet counts weekly during induction and initial maintenance cycles. It is recommended to avoid anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs (NSAIDs) when the platelet count is less than 50,000/µL as they may increase the risk of bleeding. Caution is recommended when using this agent in patients at risk of bleeding episodes.
Bone Marrow Depression/Low Blood Counts
Moderate:
omacetaxine
Omacetaxine has a moderate potential interaction with Bone Marrow Depression/Low Blood Counts.
The use of omacetaxine might cause hematological toxicities. Patients with neutropenia are at increased risk for infections, and should be monitored frequently and advised to contact a physician if they have symptoms of infection or fever. It is recommended to monitor complete blood counts (CBCs) weekly during induction and initial maintenance cycles and every two weeks during later maintenance cycles, as clinically indicated. After initial maintenance cycles, monitor CBCs every two weeks or as clinically indicated. Care should be exercised when using omacetaxine in patients with hematological disorders.
Diabetes Mellitus
Moderate:
omacetaxine
Omacetaxine has a moderate potential interaction with Diabetes Mellitus.
The use of omacetaxine can induce glucose intolerance. Hyperglycemia has been reported in patients using omacetaxine. It is recommended to monitor blood glucose levels frequently, especially in patients with a history of diabetes or in those with risk factors for diabetes. Avoid the use of omacetaxine in patients with poorly controlled diabetes.
High Cholesterol
Moderate:
sirolimus
Sirolimus has a moderate potential interaction with High Cholesterol.
The use of sirolimus may increase serum cholesterol and triglycerides. Care should be taken when prescribing this agent to hyperlipidemic patients. It is recommended to assess the risk/benefit carefully when considering this agent in patients with established hyperlipidemia before initiating therapy. It is recommended to monitor patients regularly for elevated lipids.
Immunodeficiency
Major:
sirolimus
Sirolimus has a major potential interaction with Immunodeficiency.
Immunosuppressive agents may increase the risk of progressive multifocal leukoencephalopathy (PML). Certain agents are contraindicated in patients who have or have had PML. Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not be treated with these agents. Health care professionals should monitor patients for any new sign or symptom suggestive of PML. Therapy dosing should be withheld immediately and an appropriate diagnostic evaluation should be performed at the first sign or symptom suggestive of PML.
Infection
Major:
sirolimus
Sirolimus has a major potential interaction with Infection.
Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents. Patients receiving immunosuppressants are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections including opportunistic infections. Caution should be exercised when considering their use in patients with severe or chronic infections. It is recommended to interrupt therapy in patients who develop a new infection while undergoing treatment and to monitor these patients closely for any sign or symptom indicative of infection.
Liver Disease
Moderate:
sirolimus
Sirolimus has a moderate potential interaction with Liver Disease.
Sirolimus is extensively metabolized in the intestinal wall and liver and undergoes counter-transport from enterocytes of the small intestine into the gut lumen. The maintenance dose of sirolimus should be reduced by approximately one third in patients with mild or moderate hepatic impairment and by approximately one half in patients with severe hepatic impairment. It is not necessary to modify the sirolimus loading dose. Care should be taken when prescribing this agent to patients with liver impairment and close monitoring is recommended.
Organ Transplant
Moderate:
sirolimus
Sirolimus has a moderate potential interaction with Organ Transplant.
The use of sirolimus in lung transplant patients is not recommended as the safety and efficacy of this agent as immunosuppressive therapy has not been established in these patients. 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.
Moderate:
sirolimus
Sirolimus has a moderate potential interaction with Organ Transplant.
The use of sirolimus is not recommended in liver transplant patients as its safety and efficacy has not been established in these patients. The use of sirolimus has been associated with adverse outcomes in patients following liver transplantation, including excess mortality, graft loss and hepatic artery thrombosis.
Pulmonary Impairment
Moderate:
sirolimus
Sirolimus has a moderate potential interaction with Pulmonary Impairment.
Interstitial Lung Disease (ILD)/Pneumonitis, including pneumonitis, bronchiolitis obliterans organizing pneumonia, and pulmonary fibrosis, some fatal, with no identified infectious etiology have occurred with the use of sirolimus. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis and discontinue sirolimus and assess patients developing ILD or pneumonitis.
Renal Dysfunction
Moderate:
sirolimus
Sirolimus has a moderate potential interaction with Renal Dysfunction.
Renal function should be closely monitored during the co-administration of sirolimus with cyclosporine, because long-term administration of the combination has been associated with deterioration of renal function. It is recommended to adjust therapy regimen, including discontinuation of sirolimus and/or cyclosporine in patients with elevated or increasing serum creatinine levels. Caution should be exercised when using agents (e.g., aminoglycosides and amphotericin B) that are known to have a deleterious effect on renal function. Periodic monitoring of renal function is recommended, including quantitative monitoring of urinary protein excretion.
Thrombocytopenia
Moderate:
omacetaxine
Omacetaxine has a moderate potential interaction with Thrombocytopenia.
Omacetaxine can cause severe thrombocytopenia. Bleeding events, including fatalities from cerebral hemorrhage, and severe, non-fatal, gastrointestinal hemorrhages have been reported in clinical trials. Perform complete blood counts, including platelet counts weekly during induction and initial maintenance cycles. It is recommended to avoid anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs (NSAIDs) when the platelet count is less than 50,000/µL as they may increase the risk of bleeding. Caution is recommended when using this agent in patients at risk of bleeding episodes.
More resources
omacetaxine
A total of 605 drugs are known to interact with omacetaxine.
- Omacetaxine is in the drug class miscellaneous antineoplastics.
- Omacetaxine is used to treat Chronic Myelogenous Leukemia.
sirolimus
A total of 756 drugs are known to interact with sirolimus.
- Sirolimus is in the following drug classes: mTOR inhibitors, selective immunosuppressants.
- Sirolimus is used to treat the following conditions:
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
Further information
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