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Multiple Sclerosis - Medications

dalfampridine -AMPYRA® dimethyl fumarate -TECFIDERA™
fingolimod - GILENYA™ glatiramer (Copaxone® )
interferon beta-1A (Avonex ® , Rebif ® ) interferon beta-1B (Betaseron ®)
Interferon beta-1b - Extavia® Kit teriflunomide - AUBAGIO®
Disclaimer - Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer

dalfampridine -AMPYRA®  top of page

DESCRIPTION
AMPYRA (dalfampridine) is a potassium channel blocker, available in a 10 mg tablet strength. Each tablet contains 10 mg dalfampridine, formulated as an extended release tablet for twice-daily oral administration. Dalfampridine is also known by its chemical name, 4-aminopyridine.

INDICATIONS AND USAGE
AMPYRA™ (dalfampridine) is a potassium channel blocker indicated to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed

DOSAGE AND ADMINISTRATION
Maximum recommended dose: 10 mg twice daily (approximately 12 hours apart) with or without food.
Patients should not take double or extra doses if a dose is missed. No additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse events, including seizures, were more frequent at higher doses.
Tablets should only be taken whole; do not divide, crush, chew, or dissolve.

Renal impairment: AMPYRA is contraindicated in patients with moderate or severe renal impairment; the risk of seizures in patients with mild renal impairment is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures.

HOW SUPPLIED
AMPYRA (dalfampridine) extended release tablets, 10 mg are a film-coated, white to off-white, biconvex, oval shaped, non-scored tablets with flat edge. The tablets are identified by a debossed code "A10" on one side and are available in bottles of 60.

fingolimod - GILENYA™: top of page

INDICATIONS AND USAGE:
GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. Pregnancy registry available.
Pediatric patients: Safety and effectiveness not established.
Hepatic impairment: Monitor patients with severe hepatic impairment closely, as GILENYA exposure is doubled, and risk of adverse reactions is greater.

DOSAGE AND ADMINISTRATION:
Recommended dose: 0.5 mg orally once daily, with or without food.

First Dose Monitoring:
  • Observe all patients for signs and symptoms of bradycardia for at least 6 hours after first dose with hourly pulse and blood pressure measurement. Obtain ECG prior to dosing and at the end of the observation period.
  • Patients who develop a heart rate <45 bpm, or a new onset 2nd degree or higher atrioventricular block should be monitored until resolution of the finding. Patients at lowest post-dose heart rate at the end of the observation period should be monitored until heart rate increases.
  • In patients experiencing symptomatic bradycardia, begin continuous ECG monitoring until the symptoms have resolved; if pharmacological intervention is required to treat bradycardia, continuous ECG monitoring should continue overnight in a medical facility, and first-dose monitoring procedures should be repeated for the second dose.
  • Patients at higher risk of symptomatic bradycardia or heart block because of a coexisting medical condition or certain concomitant medications should be observed overnight with continuous ECG monitoring .
  • Patients with prolonged QTc interval at baseline or during the observation period, or taking drugs with known risk of torsades de pointes should be observed overnight with continuous ECG monitoring
DOSAGE FORMS AND STRENGTHS:
.5 mg hard capsules.


CONTRAINDICATIONS:
Recent (within the last 6 months) occurrence of: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure.

History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker.

Baseline QTc interval geq500 ms.

Treatment with Class Ia or Class III anti-arrhythmic drugs.


WARNINGS AND PRECAUTIONS
  • Decrease in heart rate and/or atrioventricular conduction after first dose of GILENYA: Monitor patients
  • Infections: GILENYA may increase the risk of infections. A recent CBC should be available before initiating treatment with GILENYA. Monitor for signs and symptoms of infection during treatment and for two months after discontinuation. Do not start GILENYA treatment in patients with active acute or chronic infections.
  • Macular edema: Can occur with or without visual symptoms. An ophthalmologic evaluation should be performed before starting GILENYA and at 3-4 months after treatment initiation. Monitor visual acuity at baseline and during routine evaluations of patients. Patients with diabetes mellitus or a history of uveitis are at increased risk and should have regular ophthalmologic evaluations.
  • Decrease in pulmonary function tests with GILENYA: Obtain spirometry and diffusion lung capacity for carbon monoxide (DLCO) when clinically indicated.
  • Hepatic effects: GILENYA may increase liver transaminases. Recent liver enzyme results should be available before starting GILENYA. Assess liver enzymes if hepatic injury is suspected. Discontinue GILENYA if significant liver injury occurs
  • Fetal risk: Women of childbearing potential should use effective contraception during and for 2 months after stopping GILENYA


ADVERSE REACTIONS
Most common adverse reactions (incidence geq110% and > placebo): Headache, influenza, diarrhea, back pain, liver transaminase elevations and cough.

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Ketoconazole: Monitor patients closely, as GILENYA exposure is increased by 70% during concomitant use with systemic ketoconazole, and risk of adverse reactions is greater.

Vaccines: Avoid live attenuated vaccines during, and for 2 months after stopping GILENYA treatment, due to risk of infection.

glatiramer (Copaxone® ) top of page

Mechanism of Action
The mechanism(s) by which glatiramer acetate exerts its effects in patients with Multiple Sclerosis (MS) is (are) not fully elucidated. However, it is thought to act by modifying immune processes that are currently believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental allergic encephalomyelitis (EAE), a condition induced in several animal species through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery.

Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally occurring immune responses. Results of a limited battery of tests designed to evaluate this risk produced no finding of concern; nevertheless, there is no logical way to absolutely exclude this possibility.

INDICATIONS AND USAGE
COPAXONE® Injection is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.

CONTRAINDICATIONS
COPAXONE® Injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

WARNINGS
The only recommended route of administration of COPAXONE® Injection is the subcutaneous route. COPAXONE® Injection should not be administered by the intravenous route

Dosing (Adults):  (usual)
SubQ: 20 mg daily

Administration
For SubQ administration in the arms, abdomen, hips or thighs. Bring to room temperature prior to use.

SUPPLIED:
Injection, solution [preservative free]: 20 mg/mL (1 mL) [prefilled syringe; contains mannitol; packaged with alcohol pads]

interferon beta-1A  (Avonex ® , Rebif ® ) top of page

DOSING (Adults): Note: Analgesics and/or antipyretics may help decrease flu-like symptoms on treatment days:
I.M. (Avonex®): 30 mcg once weekly

SubQ (Rebif®): Doses should be separated by at least 48 hours:
Target dose 44 mcg 3 times/week:
Initial: 8.8 mcg (20 % of final dose) 3 times/week for 8 weeks
Titration: 22 mcg (50% of final dose) 3 times/week for 8 weeks
Final dose: 44 mcg 3 times/week

Target dose 22 mcg 3 times/week:
Initial: 4.4 mcg (20 % of final dose) 3 times/week for 8 weeks
Titration: 11 mcg (50% of final dose) 3 times/week for 8 weeks
Final dose: 22 mcg 3 times/week

Dosage adjustment in hepatic impairment: Rebif®: If liver function tests increase or in case of leukopenia: Decrease dose 20% to 50% until toxicity resolves


Administration
Avonex®: Must be administered by I.M. injection

Rebif®: Administer SubQ at the same time of day on the same 3 days each week (ie, late afternoon/evening Mon, Wed, Fri); rotate injection site

SUPPLIED:
Combination package [preservative free] (Rebif® Titration Pack):
Injection, solution: 8.8 mcg/0.2 mL (0.2 mL) [6 prefilled syringes; contains albumin]
Injection, solution: 22 mcg/0.5 mL (0.5 mL) [6 prefilled syringes; contains albumin]

Injection, powder for reconstitution (Avonex®): 33 mcg [6.6 million units; provides 30 mcg/mL following reconstitution] [contains albumin; packaged with SWFI, alcohol wipes, and access pin and needle]

Injection, solution (Avonex®): 30 mcg/0.5 mL (0.5 mL) [albumin free; prefilled syringe; syringe cap contains latex; packaged with alcohol wipes, gauze pad, and adhesive bandages]

Injection, solution [preservative free] (Rebif®): 22 mcg/0.5 mL (0.5 mL) [prefilled syringe; contains albumin]; 44 mcg/0.5 mL (0.5 mL) [prefilled syringe; contains albumin]

interferon beta-1B  (Betaseron ®) top of page

DOSING (Adults):
SubQ:
Children <18 years: Not recommended
Adults: 0.25 mg (8 million units) every other day

Administration
Withdraw 1 mL of reconstituted solution from the vial into a sterile syringe fitted with a 27-gauge needle and inject the solution subcutaneously; sites for self-injection include arms, abdomen, hips, and thighs

SUPPLIED:
Injection, powder for reconstitution [preservative free]: 0.3 mg [9.6 million units]
Recommended dose: 0.25 mg injected subcutaneously every other day.

Interferon beta-1b - Extavia® Kit: top of page

INDICATIONS AND USAGE:
Extavia is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm.
Nursing Mothers: use EXTAVIA with caution.
Pediatric Use: Safety and efficacy not established in patients under 18 years of age.
Geriatric Use: Safety and efficacy not established in patients age 65 years or older.

DOSAGE AND ADMINISTRATION:
For subcutaneous use only.

The recommended dose is 0.25 mg injected subcutaneously every other day. Generally, start at 0.0625 mg (0.25 mL) subcutaneously every other day, and increase over a six week period to 0.25 mg (1 mL) every other day.

Instruct patients in the use of aseptic technique when administering Extavia.

DOSAGE FORMS AND STRENGTHS:
Lyophilized powder containing 0.3 mg of Interferon beta-1b, 15 mg Albumin (Human), USP, and 15 mg Mannitol, USP.


CONTRAINDICATIONS:
History of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), USP, or any other component of the formulation.

WARNINGS AND PRECAUTIONS
  • epression and suicide: advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuation of Extavia if depression occurs.
  • Injection site necrosis: do not administer Extavia into affected area until it is fully healed; if multiple lesions occur, therapy should be discontinued until healing occurs.
  • Injection site reactions.
  • Anaphylaxis and other allergic reactions. 
  • Flu-Like Symptom Complex.
  • Leukopenia: monitor CBC.
  • Liver enzymes abnormalities: monitor liver function tests.
  • Monitor thyroid function tests every 6 months in patients with history of thyroid dysfunction.


ADVERSE REACTIONS
In controlled studies with interferon beta-1b, the most common adverse reactions (at least 2% more than placebo) were: Lymphopenia, neutropenia, leukopenia, lymphadenopathy, headache, insomnia, incoordination, hypertension, dyspnea, abdominal pain, increased liver enzymes, rash, skin disorder, hypertonia, myalgia, urinary urgency, metrorrhagia, impotence, injection site reaction, asthenia, flu-like symptom complex, pain, fever, chills, peripheral edema, chest pain, malaise, and injection site necrosis

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
No formal drug interaction studies have been conducted.


teriflunomide - AUBAGIO®: top of page

WARNINGS:
 HEPATOTOXICITY and RISK OF TERATOGENICITY
See full prescribing information for complete boxed warning

INDICATIONS AND USAGE
AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis

DOSAGE AND ADMINISTRATION
7 mg or 14 mg orally once daily, with or without food.

DOSAGE FORMS AND STRENGTHS
7 mg and 14 mg film-coated tablets

CONTRAINDICATIONS:
Severe hepatic impairment
Pregnancy
Current leflunomide treatment
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Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.  David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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