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Mitigare and Neoral

Determining the interaction of Mitigare and Neoral and the possibility of their joint administration.

Check result:

Mitigare <> Neoral

Relevance: 09.04.2023 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Using colchicine together with cycloSPORINE may elevate the blood levels of both drugs to dangerous levels, increasing the risk of serious side effects that can affect your muscles, blood cells, nervous system, and multiple organs including the liver and kidneys. You may need a lower dose of colchicine if you are currently using cycloSPORINE or have used it within the last 14 days. Your doctor may also need to monitor your cycloSPORINE levels more frequently to determine if any dose adjustments are needed. Let your doctor know if your condition changes or you experience abdominal pain, nausea, vomiting, diarrhea, fever, muscle pain, weakness, fatigue, and/or numbness or tingling in your hands and feet. You may not be able to take these medications together if you have liver or kidney disease. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

ADJUST DOSE: Coadministration of cyclosporine and colchicine may significantly increase the plasma concentrations of both drugs. The proposed mechanism is competitive inhibition of P-glycoprotein (P-gp) efflux transporter in the intestine, renal proximal tubule and liver, resulting in increased drug absorption and decreased excretion. Competitive inhibition of CYP450 3A4 metabolism may also be involved. In a study of 23 healthy volunteers, administration of a single 0.6 mg dose of colchicine in combination with a single 100 mg dose of cyclosporine resulted in an approximately 3.5-fold increase in colchicine peak plasma concentration (Cmax) and systemic exposure (AUC). The pharmacokinetics of cyclosporine were not reported in the study, although elevated cyclosporine levels requiring dose reduction have been noted in reports of suspected interaction with colchicine. Clinical manifestations associated with the interaction have included neuromyopathy, rhabdomyolysis, hepato- and nephrotoxicity, cardiotoxicity, bone marrow suppression, multiorgan failure, and fatality. In a retrospective study of renal transplant recipients at a French hospital, investigators reported that five out of ten patients who received cyclosporine in combination with colchicine experienced muscular symptoms, while none did in the control group that received only cyclosporine. Muscular histology, when performed, was consistent with previous reports of colchicine (i.e., vacuolar) myopathy. Mean duration of colchicine therapy was 12.2 months in the patients with muscular symptoms and 6.8 months in the patients without muscular symptoms. All five patients improved after colchicine withdrawal. No significant differences were found for age, gender ratio, transplant duration, serum creatinine levels, or cumulative steroid dose between case patients and controls.

MANAGEMENT: Due to the risk of life-threatening and fatal toxicity, patients with renal or hepatic impairment should not be given colchicine in combination cyclosporine. In patients with normal renal and hepatic function, the dosage of colchicine should be reduced when used with or within 14 days of cyclosporine therapy. For the treatment of acute gout flares, the adjusted dosage recommended is 0.6 mg for one dose. Administration should not be repeated for at least three days. For the treatment of familial Mediterranean fever, the maximum dosage of colchicine is 0.6 mg/day when used in the presence of cyclosporine. Patients should be advised to contact their physician if they experience symptoms of toxicity such as abdominal pain, nausea, vomiting, diarrhea, fatigue, myalgia, asthenia, hyporeflexia, paresthesia, and numbness. In addition, cyclosporine blood levels, serum electrolytes, as well as renal and hepatic function should be carefully monitored, and the cyclosporine dosage adjusted as necessary.

References

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Francis L, Bonilla E, Soforo E, et al. "Fatal toxic myopathy attributed to propofol, methylprednisolone, and cyclosporine after prior exposure to colchicine and simvastatin." Clin Rheumatol 27 (2008): 129-31
Lee BI, Shin SJ, Yoon SN, Choi YJ, Yang CW, Bang BK "Acute myopathy induced by colchicine in a cyclosporine-treated renal transplant recipient--a case report and review of the literature." J Korean Med Sci 12 (1997): 160-1
Ducloux D, Schuller V, Bresson-Vautrin C, Chalopin JM "Colchicine myopathy in renal transplant recipients on cyclosporin." Nephrol Dial Transplant 12 (1997): 2389-92
Caglar K, Safali M, Yavuz I, Odabasi Z, Yenicesu M, Vural A "Colchicine-induced myopathy with normal creatine phosphokinase level in a renal transplant patient." Nephron 92 (2002): 922-924
Vasudevan AR, Uthamalingam S, Kumar S, Tamarin F, Brensilver JM "Colchicine-induced rhabdomyolysis: the whole is greater than the sum of its parts!" Am J Med 115 (2003): 249
Eleftheriou G, Bacis G, Fiocchi R, Sebastiano R "Colchicine-induced toxicity in a heart transplant patient with chronic renal failure." Clin Toxicol (Phila) 46 (2008): 827-30
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Yussim A, Barnathan N, Lustig S, Shaharabani E, Geier E, Shmuely D, Nakache R, Shapira Z "Gastrointestinal, hepatorenal, and neuromuscular toxicity caused by cyclosporine-colchicine interaction in renal transplantation." Transplant Proc 26 (1994): 2825-6
"Product Information. Colcrys (colchicine)." AR Scientific Inc, Philadelphia, PA.
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Gruberg L, Har-Zahav Y, Agranat O, Freimark D "Acute myopathy induced by colchicine in a cyclosporine treated heart transplant recipient: possible role of the multidrug resistance transporter." Transplant Proc 31 (1999): 2157-8
Garrouste C, Philipponnet C, Kaysi S, Enache I, Tiple A, Heng AE "Severe colchicine intoxication in a renal transplant recipient on cyclosporine." Transplant Proc 44 (2012): 2851-2
Kuncl RW, Duncan G, Watson D, et al "Colchicine myopathy and neuropathy." N Engl J Med 316 (1987): 1562-8
Fujii Y, Arimura Y, Takahashi N, et al. "[A case of Behcet's disease associated with neuromyopathy induced by combination therapy with colchicine and cyclosporin]" Ryumachi 43 (2003): 44-50

Mitigare

Generic Name: colchicine

Brand name: Colcrys, Mitigare

Synonyms: n.a.

What is Mitigare?

Neoral

Generic Name: cyclosporine

Brand name: Gengraf, Neoral, Sandimmune, Sandimmune

Synonyms: Neoral (Capsules, Modified)

What is Neoral?

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In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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