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New drug brings relief to Crohn’s patients
With the introduction of Malvern, PA-based Centocor’s Remicade (infliximab), patients with Crohn’s disease have new hope for putting the disease in remission — with either one or three home infusions of the drug. As patients have begun being treated by the drug, first available last August, favorable outcomes are pouring in.
"One gentleman made the comment that it was the first time in two years he had been able to go out to eat with his wife," says Ann Williams, RN, CRNI, an IV nurse consultant and infusion nurse with Deaconess Home Medical Equipment and Infusion in Evansville, IN.
According to Centocor’s literature on Remicade, the drug is for:
"1. Treatment of moderately to severely active Crohn’s disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapy.
"2. Treatment of patients with fistulizing Crohn’s disease of the reduction in the number of draining enterocutaneous fistula(s)."
According to the drug’s literature, the recommended dose of Remicade is 5mg/kg, given as a single IV infusion for patients who fall under category No. 1 listed above. Patients who fall under category No. 2, with fistulizing Crohn’s disease, receive the initial 5mg/kg dose, followed with additional 5 mg/kg doses at two and six weeks after the first infusion.
The literature adds that "the safety and efficacy of therapy continued beyond three doses have not been studied." However, in earlier studies, 82% of patients receiving Remicade experienced "significant improvement."
While the drug can be first dosed in the home, Centocor notes that only non-PVC bags and tubing should be used.
"It leaches DEHP into the solution; we don’t know what the risk of long-term exposure is," says Heidi Brubaker, RPh, a medical consultant with Centocor. "Remicade is the only drug we have that recommendation for."
Williams, along with pharmacist Mark Roy, PharmD, established the following policy for the home infusion of Remicade. After creating it, Williams made one minor change to account for the use of non-PVC bags and lines.
"We initially said to use a flow regulator to adjust the rate, but I don’t know that any flow regulators come with non-PVC (lines). We changed the policy to reflect calculating the drip rate," she says. "We feel with a nurse present throughout the infusion, it is perfectly safe to calculate the drip rate and monitor throughout the infusion."
— Usual dose is 5mg/kg, mixed in 250ml, .9% sodium chloride.
— First dose may be given in the home.
— Non-PVC tubing and containers.
— 1.2-micron filter.
— Should not infuse any other drug through the same line.
— May be either peripheral or central access.
— Have IV access before preparing Remicade.
— 10 ml sterile water for each vial of Remicade.
— Inject sterile water, direct to side of Remicade vial.
— Foaming not unusual.
— Do not shake.
— Swirl gently or roll in your hands until dissolved.
— Allow to stand five minutes.
— Remove equal volume from bag of .9% NaCl as you will replace with Remicade.
— Inject all Remicade into bag.
— Gently massage the bag; do not shake.
— Label bag with patient’s name, drug, dose, date, time of prep, and initial it.
— Infuse over no less than two hours.
— 250ml/2 hours is 8 gtts/15 seconds.
— Count drips.
— Check pulse and BP q30min.
— Observe patient 30-60 minutes following infusion.
• Side effects:
— Monitor patient for hypersensitivity reaction.
— Discontinue for severe reactions.
— Fever, chills, pruritus, urticaria, chest pain, hypo/hypertension, dyspnea, and headache.
— Some cases treated with acetaminophen, antihistamines, corticosteroids, and/or epi.
— Rapid resolution following d/c.
— Inform patient/caregiver that patient may have increased risk of infection.
Williams points out that insurance companies are reimbursing the drug’s cost, although the first patient Deaconess was to treat with Remicade was turned down by insurance. She is uncertain as to why the patient was turned down; there could be numerous reasons. But for many patients, Remicade is the answer to their problems.
"From what I have heard, Remicade puts them in remission; but it is only used as a last resort when none of the other conventional therapies worked," says Williams.
She adds that Centocor petitioned to FDA in January for approval to use Remicade on patients with rheumatoid arthritis.