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Drug Interactions between meningococcal conjugate vaccine and vamorolone

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

meningococcal conjugate vaccine vamorolone

Applies to: meningococcal conjugate vaccine and vamorolone

Consumer information for this interaction is not currently available.

MONITOR: The administration of inactivated, killed, or otherwise noninfectious vaccines to immunosuppressed patients is generally safe but may be associated with a diminished or suboptimal immunologic response due to antibody inhibition. Such patients may include those who have recently received or are receiving immunosuppressive agents, antilymphocyte globulins, alkylating agents, antimetabolites, radiation, some antirheumatic agents, high dosages of corticosteroids or adrenocorticotropic agents (e.g., greater than or equal to 2 mg/kg/day or 20 mg/day of prednisone or equivalent for 14 consecutive days or more), or long-term topical or inhaled corticosteroids.

MANAGEMENT: In general, the U.S. Department of Public Health Advisory Committee on Immunization Practices (ACIP) recommends that inactivated or killed vaccines be administered to non-HIV immunosuppressed patients according to the same guidelines as for healthy patients. However, higher dosages, more frequent boosters, and/or serological testing may be required in some cases. Local guidelines and prescribing information for individual vaccines should be consulted. For Haemophilus influenzae b vaccine, some experts recommend that it be administered at least 2 weeks before starting or 3 months after discontinuing chemotherapy when used in patients with Hodgkin's disease. For rabies vaccine, some authorities suggest that immunosuppressive agents should generally be avoided during postexposure therapy except when absolutely necessary for the treatment of other conditions. For SARS-CoV-2 (COVID-19) vaccines, vaccination should generally be completed at least 2 weeks before initiation or resumption of immunosuppressive therapies; however, decisions to delay or temporarily withhold immunosuppressive therapy to complete COVID-19 vaccination should consider the individual's risks relative to their underlying condition. Some authorities recommend administering the COVID-19 vaccine approximately 4 weeks prior to the next scheduled therapy for those on B-cell-depleting therapies on a continuing basis. Additional shots, boosters, and even revaccination may be appropriate depending on age, prior COVID-19 vaccine formulation(s) received, current or planned immunosuppressive therapy, and other factors in individuals with moderate to severe immune compromise due to medical conditions or immunosuppressive medications or treatments (e.g., solid organ transplant recipients on immunosuppressive therapy; patients on active treatment for solid tumor and hematologic malignancies). Vaccines may generally be administered to patients receiving corticosteroids as replacement therapy (e.g., for Addison's disease).

References

  1. "Product Information. Fluzone (influenza virus vaccine, inactivated)." Connaught Laboratories Inc
  2. "Product Information. Omnihib (haemophilus b conjugate vaccine (obsolete))." SmithKline Beecham PROD
  3. "Product Information. Havrix (HepA) (hepatitis A adult vaccine)." SmithKline Beecham PROD
  4. CDC. Centers for Disease Control and Prevention/ "Recommendations of the advisory committtee on immunization practices (ACIP): use of vaccines and immune globulins in persons with altered immunocompetence." MMWR Morb Mortal Wkly Rep 42(RR-04) (1993): 1-18
  5. "Product Information. Imovax Rabies (rabies vaccine, human diploid cell)." sanofi pasteur (2022):
  6. "Product Information. Biothrax (anthrax vaccine adsorbed)." Emergent BioSolutions Inc. (2003):
  7. Cerner Multum, Inc. "Australian Product Information." O 0
  8. "Product Information. Influenza Virus Vaccine, H5N1, Inactivated (influenza virus vaccine, H5N1, inactivated)." GlaxoSmithKline (2022):
  9. CDC Centers for Disease Control and Prevention "General Best Practice Guidelines for Immunization: Altered Immunocompetence. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.pdf" (2019):
  10. Department of Health. National Health Service "Immunisation Against Infectious Disease - "The Green Book". Chapter 6: Contraindications and special considerations. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/655225/Greenbook_chapter_6.pdf" (2019):
  11. CDC Centers for Disease Control and Prevention "Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html" (2022):
  12. Centers for Disease Control and Prevention "Use of COVID-19 vaccines in the U.S. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html" (2023):
  13. UK Health Security Agency "COVID-19: the green book, chapter 14a https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a" (2023):
  14. Public Health Agency of Canada "Immunization of immunocompromised persons: Canadian immunization guide https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-3-vaccination-specific-populations/page-8-immunization-immunocompromised-p" (2023):
  15. Public Health Agency of Canada "COVID-19 vaccines: Canadian immunization guide. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html" (2023):
  16. Australian Government. Department of Health and Aged Care "Australian immunisation handbook: COVID-19. https://immunisationhandbook.health.gov.au/contents/vaccine-preventable-diseases/covid-19" (2023):
View all 16 references

Drug and food interactions

Moderate

vamorolone food

Applies to: vamorolone

Consumer information for this interaction is not currently available.

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of vamorolone. The proposed mechanism is inhibition of CYP450 3A4-mediated metabolism in the gut wall by certain compounds present in grapefruit. The metabolism of vamorolone is mediated by the isoenzymes CYP450 3A4/5, and CYP450 2C8, and uridine diphosphate glucuronosyltransferases (UGT) 1A3, 2B7, and 2B17. In general, the effect of grapefruit juice is concentration-, dose-, and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased systemic exposure to vamorolone may increase the risk of corticosteroid adverse effects such as hypercorticism, hyperglycemia, adrenal suppression, immunosuppression, hypertension, salt and water retention, electrolyte abnormalities, behavioral and mood disturbances, posterior subcapsular cataracts, glaucoma, bone loss, and growth retardation in children and adolescents.

MANAGEMENT: Until further information is available, it may be advisable for patients to avoid the consumption of large amounts of grapefruit and grapefruit juice during vamorolone therapy unless otherwise directed by their doctor, as the interaction is unreliable and subject to a high degree of interpatient variation. If coadministration is considered necessary, patients should be closely monitored for signs and symptoms of corticosteroid adverse effects. Patients should also be monitored for signs and symptoms of hypercorticism such as acne, striae, thinning of the skin, easy bruising, moon facies, dorsocervical "buffalo" hump, truncal obesity, increased appetite, acute weight gain, edema, hypertension, hirsutism, hyperhidrosis, proximal muscle wasting and weakness, glucose intolerance, exacerbation of preexisting diabetes, and depression. Signs and symptoms of adrenal insufficiency include anorexia, hypoglycemia, nausea, vomiting, weight loss, muscle wasting, fatigue, weakness, dizziness, postural hypotension, depression, and adrenal crisis manifested as an inability to respond to stress (e.g., illness, infection, surgery, trauma). Consultation with product labeling for specific recommendations is advisable.

References

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  6. Itkin IH, Menzel ML "The use of macrolide antibiotic substances in the treatment of asthma." J Allergy Clin Immunol 45 (1970): 146-62
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  8. Finkenbine RD, Frye MD "Case of psychosis due to prednisone-clarithromycin interaction." Gen Hosp Psychiat 20 (1998): 325-6
  9. Varis T, Kaukonen KM, Kivisto KT, Neuvonen PJ "Plasma concentrations and effects of oral methylprednisolone are considerably increased by itraconazole." Clin Pharmacol Ther 64 (1998): 363-8
  10. Hillebrand-Haverkort ME, Prummel MF, ten Veen JH "Ritonavir-induced Cushing's syndrome in a patient treated with nasal fluticasone." AIDS 13 (1999): 1803
  11. Varis T, Kivisto KT, Neuvonen PJ "The effect of itraconazole on the pharmacokinetics and pharmacodynamics of oral prednisolone." Eur J Clin Pharmacol 56 (2000): 57-60
  12. Varis T, Backman JT, Kivisto KT, Neuvonen PJ "Diltiazem and mibefradil increase the plasma concentrations and greatly enhance the adrenal-suppressant effect of oral methylprednisolone." Clin Pharmacol Ther 67 (2000): 215-21
  13. Garey KW, Rubinstein I, Gotfried MH, Khan IJ, Varma S, Danziger LH "Long-term clarithromycin decreases prednisone requirements in elderly patients with prednisone-dependent asthma." Chest 118 (2000): 1826-7
  14. Lebrun-Vignes B, Archer VC, Diquest B, et al. "Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects." Br J Clin Pharmacol 51 (2001): 443-50
  15. Couturier J, Steele M, Hussey L, Pawliuk G "Steroid-induced mania in an adolescent: risk factors and management." Can J Clin Pharmacol 8 (2001): 109-12
  16. Gupta SK, Dube MP "Exogenous Cushing syndrome mimicking human immunodeficiency virus lipodystrophy." Clin Infect Dis 35 (2002): E69-71
  17. Raaska K, Niemi M, Neuvonen M, Neuvonen PJ, Kivisto KT "Plasma concentrations of inhaled budesonide and its effects on plasma cortisol are increased by the cytochrome P4503A4 inhibitor itraconazole." Clin Pharmacol Ther 72 (2002): 362-369
  18. Main KM, Skov M, Sillesen IB, et al. "Cushing's syndrome due to pharmacological interaction in a cystic fibrosis patient." Acta Paediatr 91 (2002): 1008-11
  19. Skov M, Main KM, Sillesen IB, Muller J, Koch C, Lanng S "Iatrogenic adrenal insufficiency as a side-effect of combined treatment of itraconazole and budesonide." Eur Respir J 20 (2002): 127-33
  20. Kotlyar M, Brewer ER, Golding M, Carson SW "Nefazodone inhibits methylprednisolone disposition and enhances its adrenal-suppressant effect." J Clin Psychopharmacol 23 (2003): 652-6
  21. Bolland MJ, Bagg W, Thomas MG, Lucas JA, Ticehurst R, Black PN "Cushing's syndrome due to interaction between inhaled corticosteroids and itraconazole." Ann Pharmacother 38 (2004): 46-9
  22. Edsbacker S, Andersson T "Pharmacokinetics of budesonide (Entocort EC) capsules for Crohn's disease." Clin Pharmacokinet 43 (2004): 803-21
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  24. Soldatos G, Sztal-Mazer S, Woolley I, Stockigt J "Exogenous glucocorticoid excess as a result of ritonavir-fluticasone interaction." Intern Med J 35 (2005): 67-8
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  27. Bhumbra NA, Sahloff EG, Oehrtman SJ, Horner JM "Exogenous Cushing syndrome with inhaled fluticasone in a child receiving lopinavir/ritonavir." Ann Pharmacother 41 (2007): 1306-9
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  30. "Product Information. Agamree (vamorolone)." Santhera Pharmaceuticals (US) (2023):
View all 30 references

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor 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.
Unknown No interaction information available.

Further information

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