Full Answer
How do I contact Inflectra patient assistance?
Information about the INFLECTRA patient assistance program (PfizerFlex TM) can be obtained by calling 1-855-935-3539. Treatment with infliximab for injection may result in the formation of autoantibodies and in the development of a lupus-like syndrome.
What is the Inflectra Patient Assistance Program (pfizerflex TM)?
The INFLECTRA patient assistance program (PfizerFlex TM) facilitates the administration of INFLECTRA ®. The INFLECTRA patient assistance program (PfizerFlex TM) clinics are staffed by qualified healthcare professionals specially trained in the administration of INFLECTRA ® infusions and are available across Canada.
Does the dose of Inflectra ® matter?
However, higher doses of INFLECTRA ® were associated with a slightly higher proportion of patients experiencing adverse events (97% for the 3 mg/kg dose given every 8 weeks vs. 100% for the 10 mg/kg dose given every 4 weeks), including infections (84% for the 3 mg/kg dose given every 8 weeks vs. 91% for the 10 mg/kg dose given every 4 weeks).
What infections should be suspected after Inflectra ® treatment?
In patients treated with INFLECTRA ®, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness.
Does INFLECTRA have copay assistance?
The Pfizer enCompass Co-Pay Assistance Program provides assistance for out-of-pocket drug costs associated with INFLECTRA due to co-pays, co-insurances, or deductibles, up to $20,000 per calendar year. You are responsible for the first $5 of each injection before the benefit may be used.
What is the cost of INFLECTRA?
SEB infliximab (Inflectra) is available as a 100 mg/vial solution for intravenous infusion at a manufacturer submitted price of $525.00 pervial.
What is the name of Pfizer's patient assistance program for its infliximab biosimilar in the United States?
INFLECTRA® (infliximab-dyyb) for Healthcare professionals: Inflectra (infliximab – dyyb) for Injection U.S. Physician Prescribing Information.
How is INFLECTRA supplied?
INFLECTRA (infliximab-dyyb) for injection is supplied as one single-dose vial individually packaged in a carton (NDC 0069-0809-01 100 mg vial).
What is the success rate of INFLECTRA?
The response rates, 71.4% for INFLECTRA and 75.2% for REMICADE,1 were not statistically significantly different. INFLECTRA is marketed as INFLECTRA (infliximab-dyyb) in the UnitedStates (U.S.) and under other brand names in some countries.
Why is INFLECTRA cheaper than Remicade?
Biosimilars tend to cost less than their biologic counterparts. This is because their path to approval is shorter and cheaper. Manufacturers don't need to go through the same number of clinical trials or spend as much money on research. Because of this, Inflectra is typically less expensive than Remicade.
How often do you get INFLECTRA infusions?
The recommended dosage of INFLECTRA is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active UC.
Does INFLECTRA cause weight gain?
Conclusion: Approximately 60% of Crohn's disease patients experience weight gain within the first six weeks of infliximab treatment. The weight increment correlates with improvements in inflammatory markers and disease activity.
Is INFLECTRA a chemo drug?
Infliximab is a TNF (tumor necrosis factor) blocker. It's used to treat moderate to severe Crohn's disease. It was initially designed as a chemotherapy drug to treat cancer but wasn't effective for cancer. The drug has been shown to work against autoimmune diseases like rheumatoid arthritis and Crohn's.
Does INFLECTRA weaken the immune system?
Inflectra is an immunosuppressant (a drug that weakens your immune system). So it can increase your risk of severe infection during treatment. This can include viral, fungal, or bacterial infections, which can be life threatening.
How long are INFLECTRA infusions?
The INFLECTRA infusion should begin within 3 hours of reconstitution and dilution. The infusion must be administered intravenously for at least 2 hours with an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less).
What class of drug is INFLECTRA?
Inflectra belongs to a class of similar medications called Anti-Tumor Necrosis Factor agents.
Is INFLECTRA covered by insurance?
Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), is now covered by Medicare and Medicaid. Approved by the Food and Drug Administration in April 2016, Inflectra is the first biosimilar indicated for the treatment of rheumatic and inflammatory diseases to come to market in the United States.
How often do you get INFLECTRA infusions?
The recommended dosage of INFLECTRA is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active UC.
Is INFLECTRA generic for Remicade?
Because INFLECTRA is a biosimilar to Remicade, you can expect the same treatment experience that you had with Remicade. If you're switching to INFLECTRA, your dosage typically won't change. Your doctor will determine the right dose of INFLECTRA based on your body weight, and how often you should receive it.
How often do you get INFLECTRA?
The recommended dose of INFLECTRA® is 5 mg/kg given as an intravenous infusion followed with additional similar doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter.
What should be inspected for in a parenteral drug?
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit . If visibly opaque particles, discolouration or other foreign particulates are observed, the solution should not be used.
Can Infliximab be given to renal patients?
Infliximab for injection has not been studied in patients with renal impairment. No dose recommendations can be made (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations ).
Is Infliximab safe for hepatic impairment?
Infliximab for injection has not been studied in patients with hepatic impairment. No dose recommendations can be made (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations ).
How to contact FDA Medwatch?
Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.
How much infliximab-dyyb is in a vial?
For injection: 100 mg of infliximab-dyyb as a white lyophilized powder in a single-dose vial for reconstitution and dilution.
How many vials are infliximab-dyyb?
INFLECTRA (infliximab-dyyb) for injection is supplied as one single-dose vial...
What is Pfizer Rxpathways?
Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
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