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Rx Item-Tecfidera 120 240Mg Cap 1 By Biogen

NDC 64406-0007-03 UPC/GTIN No.3-64406-00703-3 Mfg.Part No.703BRAND: TECFIDERA NDC: 64406-0007-03,64406000703 UPC: 3-64406-00703-3,364406007033 BiogenOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Tecfidera 120 240Mg Cap 1 By Biogen

$9931.07$9458.16

Item No.: RX219642/c NDC No.64406000703 UPC No.:364406007033 NDC No.64406-0007-03 UPC/GTIN No.3-64406-00703-3 MPN 703 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx219642 Tecfidera 120/240mg Cap 1 by Biogen Item No.3219642 NDC No.64406000703 UPC No.364406007033 Other Name Tecfidera Therapeutic

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TECFIDERA- dimethyl fumarate
TECFIDERA- dimethyl fumarate capsule
Biogen Idec Inc.

1 INDICATIONS AND USAGE

TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information


The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. TECFIDERA should be swallowed whole and intact. TECFIDERA should not be crushed or chewed and the capsule contents should not be sprinkled on food. TECFIDERA can be taken with or without food.

​Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Discontinuation of TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of TECFIDERA with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3)].

2.2 Blood Test Prior to Initiation of Therapy
Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy [see Warnings and Precautions (5.3)].

3 DOSAGE FORMS AND STRENGTHS

TECFIDERA is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with "BG-12 120 mg" in black ink on the body. The 240 mg capsules have a green cap and a green body, printed with "BG-12 240 mg" in black ink on the body.

​4 CONTRAINDICATIONS

​TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

​5.1 Anaphylaxis and Angioedema
​TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue TECFIDERA and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.
DESCRIPTION

TECFIDERA contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6 H8 O4 )
Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13.

TECFIDERA is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.
Patient Information TECFIDERA � ( tek" fi de" rah) (dimethyl fumarate) delayed-release capsules
What is TECFIDERA?
TECFIDERA is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS)
It is not known if TECFIDERA is safe and effective in children under 18 years of age
Who should not take TECFIDERA?
Do not use TECFIDERA if you have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to TECFIDERA or any of its ingredients. See below for a complete list of ingredients.
Before taking and while you take TECFIDERA, tell your doctor if you have or have had:
low white blood cell counts or an infection
any other medical conditions
Tell your doctor if you are:

pregnant or plan to become pregnant. It is not known if TECFIDERA will harm your unborn baby.
If you become pregnant while taking TECFIDERA, talk to your doctor about enrolling in the TECFIDERA Pregnancy Registry. You can enroll in this registry by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com. The purpose of this registry is to monitor the health of you and your baby.
breastfeeding or plan to breastfeed. It is not known if TECFIDERA passes into your breast milk. You and your doctor should decide if you will take TECFIDERA or breastfeed.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements
How should I take TECFIDERA?
Take TECFIDERA exactly as your doctor tells you to take it
The recommended starting dose is one 120 mg capsule taken by mouth 2 times a day for 7 days
The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times a day
TECFIDERA can be taken with or without food
Swallow TECFIDERA whole. Do not crush, chew, or sprinkle capsule contents on food.
Protect TECFIDERA from light. You can do this by storing the capsules in their original container.
What are the possible side effects of TECFIDERA? TECFIDERA may cause serious side effects including:
allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)
PML a rare brain infection that usually leads to death or severe disability
decreases in your white blood cell count Your doctor should do a blood test before you start treatment with TECFIDERA and while on therapy.
The most common side effects of TECFIDERA include:

flushing, redness, itching, or rash
nausea, vomiting, diarrhea, stomach pain, or indigestion
Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking TECFIDERA may reduce flushing.
These are not all the possible side effects of TECFIDERA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

General Information about the safe and effective use of TECFIDERA
Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use TECFIDERA for a condition for which it was not prescribed. Do not give TECFIDERA to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information about TECFIDERA that is written for healthcare professionals.
What are the ingredients in TECFIDERA? Active ingredient: dimethyl fumarateInactive ingredients: microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80. Capsule Shell: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.
Manufactured by: Biogen Idec Inc., Cambridge, MA 02142, www.TECFIDERA.com or call 1-800-456-2255

NDC 64406-0007-03 UPC/GTIN No.3-64406-00703-3 Mfg.Part No.703
RX ITEM-Tecfidera 120 240Mg Cap 1 By Bio
NDC 64406-0007-03 UPC/GTIN No.3-64406-00703-3 Mfg.Part No.703

BRAND: TECFIDERA NDC: 64406-0007-03,64406000703 UPC: 3-64406-00703-3,364406007033 Biogen
Tecfidera 120 240Mg Cap 1 By Biogen
BRAND: TECFIDERA NDC: 64406-0007-03,64406000703 UPC: 3-64406-00703-3,364406007033 Biogen

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
DIMETHYL FUMARATE ORAL CA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.