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Rx Item-HADLIMA PushTouch Autoinjector Carton - 40 mg/0.8 mL by Merck

RX00006-5032-02Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.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

Rx Item-HADLIMA PushTouch Autoinjector Carton - 40 mg/0.8 mL by Merck

$0.00

NDC No. 00006-5032-02 0006-5032-02 0006503202 00006503202 UPC/GTIN No. 3-00065-03202-3 300065-032023 300065032023 MPN No. 3202- 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 Scope Of their Practice Can Order Rx Item.For: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn

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HADLIMA (ada limumab-bwwd) is supplied as a preserva tive-free, sterile, clear to opalescent, and colorless to pale brown solution for subcutaneous administration. The following packaging configurations are availa ble. ?HADLIMA PushTouch Autoinjector Carton - 40 mg/0.8 mL HADLIMA is supplied in a carton containing two dose packs. Each pack consists of a single-dose autoinjector, c ontaining a 1 mL prefilled glass syringe with a fixed � inch needle, providing 40 mg/0.8 mL of HADLIMA. The NDC number is 0006-5032-02. ?HADLIMA Prefilled Syringe Carton -40 mg/0.8 mL HADLIMA is supplied in a carton containing two dose packs. Each pack consists of a single-dose, 1 mL prefilled glass syringe with a fixed � inch needle, providing 40 mg/0.8 mL of HADLIMA. The NDC number is 0006-5031-02. Storage and Stability Do not use beyond the ex piration date on the container. HADLIMA must be refrigerated at 36�F to 46�F (2�C to 8�C) . DO NOT FREEZE. Do not use if frozen even if it has been thawed. Store in original carton until time of administration to protect from light. If needed, for example when trave ling, HADLIMA may be stored at room temperature up to a max imum of 77�F (25�C) for a period of up to 14 days, with protection from light. HADLIMA should be discarded. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not in clude all the information needed to use HADLIMA safely and effectively. See full prescribing information fo r HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Appro val: 2019 HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab) WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS (5.1, 6.1): ?Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ?Discontinue HADLIMA if a patient develops a serious infection or sepsis during treatment. ?Perform test for latent TB; if positive, start treatment for TB prior to starting HADLIMA. ?Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY (5.2): ?Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. ?Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. ------------------------INDICATIONS AND USAGE------------------------�HADLIMA is a tumor necrosis factor (TNF) blocker indicated for treatment of: ?Rheumatoid Arthritis (RA) (1.1): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ?Juvenile Idiopathic Arthritis (JIA) (1.2): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older. ?Psoriatic Arthritis (PsA) (1.3): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. ?Ankylosing Spondylitis (AS) (1.4): Reducing signs and symptoms in adult patients with active AS. ?Adult Crohn�s Disease (CD) (1.5): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn�s Disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products. ?Ulcerative Colitis (UC) (1.6) : Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6�mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers. ?Plaque Psoriasis (Ps) (1.7) : The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. --------------------DOSAGE AND ADMINISTRATION-------------------�?Administered by subcutaneous injection (2)Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis(2.1):?40 mg every other week. ?Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week. Juvenile Idiopathic Arthritis (2.2): ?? 30 kg (66 lbs): 40 mg every other week Adult Crohn's Disease and Ulcerative Colitis (2.3, 2.4) : ?Initial dose (Day 1): 160 mg ?Second dose two weeks later (Day 15): 80 mg ?Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week. ?For patients with Ulcerative Colitis only: Only continue HADLIMA in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. Plaque Psoriasis (2.5): ?80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. ------------------DOSAGE FORMS AND STRENGTHS------------------�?Injection: 40 mg/0.8 mL in a single-dose prefilled autoinjector (HADLIMA PushTouch) (3) ?Injection: 40 mg/0.8 mL in a single-dose prefilled glass syringe (3) ---------------------------CONTRAINDICATIONS---------------------------�None (4) ---------------------WARNINGS AND PRECAUTIONS--------------------�?Serious infections: Do not start HADLIMA during an active infection. If an infection develops, monitor carefully, and stop HADLIMA if infection becomes serious (5.1) ?Invasive fungal infections: For patients who develop a systemic illness on HADLIMA, consider empiric antifungal ther apy for those who reside or travel to regions where mycoses are endemic (5.1) ?Malignancies: Incidence of malignancies was greater in adalimumab-treated pa tients than in controls (5.2) ?Anaphylaxis or serious allergic reactions may occur (5.3) ?Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If re activation occurs, stop HADLIMA and begin an ti- viral therapy (5.4) ?Demyelinating disease: Exacerbation or new onset, may occur (5.5) ?Cytopenias, pancytopenia: Advise patients t o seek immediate medical atten tion if symptoms develop, and consider stopping HADLIMA (5.6) ?Heart fa ilure: Worse ning or new onset, may occur (5.8) ?Lupus-like syndrome: Stop HADLIMA if syndrome develops (5.9) ---------------------------ADVERSE REACTIONS---------------------------�Most co mmon adverse re actions (incidence >10%): infections (e.g. upper respiratory, sinusitis), injection site reactions, heada che and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1- 877�888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwat ch. ----------------------------DRUG INTERACTIONS---------------------------�?Abatacept: Increased risk of serious infection (5.1, 5.11, 7.2) ?Anakinra: Increased risk of serious infection (5.1, 5.7, 7.2) ?Live vaccines: Avoid use with HADLIMA (5.10, 7.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of HADLIMA has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Revised: 07/2019

RX00006-5032-02
Rx Item-HADLIMA PushTouch Autoinjector C
RX00006-5032-02

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-HADLIMA PushTouch Autoinjector C
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

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
AmericanPharmaWholesale.com
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