Cyclosporine

Cyclosporine has been used with benefit in Severe acute & steroid refractory Ulcerative colitis / IBD (unlabeled use).

Cyclosporine is available as

• Capsules 25 mg, 50 mg, 100 mg (Sandimmune Neoral & other brands)

Ampoule Cyclosporine  50 mg /ml;  1 ml & 5ml amp (in a polyoxyethylated castor oil and ethanol). Store at controlled room temperature; do not refrigerate. Ampoules and vials should be protected from light (Dark cover).

Before using Cyclosporine, you need to check the following risks that have been assessed, look at Blood pressure, Cholesterol, Creatinine, BUN, BSL, LFTs, high K, low Mg, high uric acid (gout).  You should not be pregnant or plan to breastfeed.

The doses are spaced evenly throughout the day. Cyclosporine should be ordered for an administration time (for example) of 6 AM and 6 PM (0600/1800) in all patients. Trough levels of CsA should always be drawn as close to 5 AM OR 30-60 minutes prior to AM dose, to acquire an accurate 12-hour trough

I.V.: Cyclosporine: 2-4 mg/kg/day, infused continuously over 24 hours. (Lichtiger, 1994; Van Assche, 2003). Note: Some studies suggest no therapeutic difference between low-dose (2 mg/kg) and high-dose (4 mg/kg) cyclosporine regimens (Van Assche, 2003).

Oral: Cyclosporine: 2.3-3 mg/kg every 12 hours (De Saussure, 2005; Weber, 2006). Patients responsive to I.V. therapy should be switched to oral therapy when possible

(There is a way to safely handle & make the infusion of Cyclosporine, persons skilled with the drug know the minute. This is a topic concerning doctors & nurses, contact Dr Salunkhe directly).

Blood samples are needed to be drawn for checking the drug levels, to find if a ‘steady-state’ has been reached. There is a way to do this, this is known to skilled personnel. (Speak to Dr Salunkhe about the details). At every step, a close watch needs to keep on the use of other drugs, in case they are likely to affect the Cyclosporine drug level. Thus, it is important to let the doctor know about each drug you would use while cyclosporine is being used for you.

The initial response is 70-80% in the first 2-3 days, in case good remission is not achieved in 7 days, you may need to consider rescue surgery. In case the remission has been achieved, trough levels of the drug and some tests done to assess safety need to carry out per protocol. This is to prevent some adverse events like a rise in blood pressure, renal injury (rising creatinine) as well as seizure risk.

Drugs used concurrently that may cause renal injury

Aminoglycosides, pain relief medication, H2 blockers, tacrolimus.

Drugs that increase CsA concentrations

Calcium channel blockers, antifungals, macrolides, steroids, allopurinol, metoclopramide.

The usual incidence of minor side effects when Cyclosporine is used is overall >10%.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. All side effects will be proactively looked for and thus avoided.

The following is the list of adverse events that are associated with Cyclosporine use.

1. Cardiovascular: Hypertension (8% to 53%), edema (5% to 14%)
2. Central nervous system: Headache, dizziness (2% to 25%)
3. Dermatologic: Hirsutism (21% to 45%), abnormal facial hair (5% to 19%)
4. Endocrine & metabolic: Triglycerides increased (15%), female reproductive disorder (9% to 11%)
5. Gastrointestinal: Nausea (23%), diarrhea (3% to 13%), gum hyperplasia (2% to 16%) brush your teeth daily, abdominal discomfort
6. Neuromuscular & skeletal: Tremor (7% to 55%), paresthesia (1% to 11%), leg cramps/muscle contractions (2% to 12%)
7. Renal: Renal dysfunction/nephropathy (10% to 38%), creatinine increased (16% to ≥50%)
8. Respiratory: Upper respiratory infection (1% to 14%)
9. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby or cause other problems with the baby such as being born too early (premature) or having low birth weight. Discuss the risks and benefits with your doctor.
10. This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
11. Miscellaneous: Infection (3% to 25%) Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, and flu). Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose)