Trade Name: Kineret

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Swedish Orphan Biovitrum AB (publ)

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 100 mg/.67mL

Storage and handling

ANAKINRA Interleukin 1 Receptor Antagonists [MoA],Interleukin-1 Receptor Antagonist [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • No data
  • KINERET is an interleukin-1 receptor antagonist indicated for:n
  • Rheumatoid Arthritis (RA)
  • Cryopyrin-Associated Periodic Syndromes (CAPS)
  • Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
  • Rheumatoid Arthritis (RA)
  • Cryopyrin-Associated Periodic Syndromes (CAPS)
  • Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
  • See full prescribing information for administration instructions ()n
  • Injection: 100 mg/0.67 mL solution in a single-use prefilled syringe for subcutaneous injection. Graduated syringe allows for doses between 20 and 100 mg.n
  • Injection: 100 mg/0.67 mL solution in a single-use prefilled syringe for subcutaneous injection. Graduated syringe allows for doses between 20 mg and 100 mg. ()n
  • KINERET is contraindicated in patients with known hypersensitivity to -derived proteins, KINERET, or any components of the product .n
  • Known hypersensitivity to -derived proteins, Kineret, or to any component of the product. ()n
  • No data
  • In RA, discontinue use if serious infection develops. In KINERET-treated NOMID or DIRA patients, the risk of a disease flare when discontinuing KINERET treatment should be weighed against the potential risk of continued treatment. Do not initiate KINERET in patients with active infections. ()n
  • Use in combination with Tumor Necrosis Factor (TNF) blocking agents is not recommended ()n
  • Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported. Patients with DIRA may have an increased risk of allergic reactions, particularly in the first several weeks after starting KINERET treatment ()n
  • The impact of treatment with KINERET on active and/or chronic infections and the development of malignancies is not known ()n
  • Live vaccines should not be given concurrently with KINERET ()n
  • Neutrophil counts should be assessed prior to initiating KINERET treatment, and while receiving KINERET, monthly for 3 months, and thereafter quarterly for a period up to 1 year ()n
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.n
  • Rheumatoid Arthritis (RA)
  • Most common adverse reactions (incidence u2265 5%) are injection site reaction, worsening of rheumatoid arthritis, upper respiratory tract infection, headache, nausea, diarrhea, sinusitis, arthralgia, flu like-symptoms, and abdominal pain ()n
  • NOMID
  • The most common AEs during the first 6 months of treatment (incidence >u00a010%) are injection site reaction, headache, vomiting, arthralgia, pyrexia, and nasopharyngitis ()n
  • DIRA
  • The most common AEs are upper respiratory tract infections, rash, pyrexia, influenza like illness, and gastroenteritis ()n
  • No drug-drug interaction studies in human subjects have been conducted. Toxicologic and toxicokinetic studies in rats did not demonstrate any alterations in the clearance or toxicologic profile of either methotrexate or KINERET when the two agents were administered together.n
  • A higher rate of serious infections has been observed in patients treated with concurrent KINERET and etanercept therapy than in patients treated with etanercept alone . Two percent of patients treated concurrently with KINERET and etanercept developed neutropenia (ANC < 1 x 10/L). Use of KINERET in combination with TNF blocking agents is not recommended.n
  • A higher rate of serious infections has been observed in RA patients treated with concurrent KINERET and etanercept therapy than in patients treated with etanercept alone. Use of KINERET in combination with TNF blocking agents is not recommended ()n
  • No data
  • Pediatric use: KINERET is indicated for use in pediatric patients with NOMID and DIRA ()n
  • Geriatric use: Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly ()n
  • Renal impairment: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function ()n
  • There have been no cases of overdose reported with KINERET in clinical trials of RA or NOMID. In sepsis trials no serious toxicities attributed to KINERET were seen when administered at mean calculated doses of up to 35 times those given patients with RA over a 72-hour treatment period.n
  • KINERET (anakinra) is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). KINERET differs from native human IL-1Ra in that it has the addition of a single methionine residue at its amino terminus. KINERET consists of 153 amino acids and has a molecular weight of 17.3 kilodaltons. It is produced by recombinant DNA technology using an bacterial expression system.n
  • KINERET is supplied in single use prefilled glass syringes with 29 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily subcutaneous (SC) administration. The solution may contain trace amounts of small, translucent-to-white amorphous proteinaceous particles. Each prefilled glass syringe contains: 0.67 mL (100 mg) of anakinra in a solution (pH 6.5) containing anhydrous citric acid (1.29 mg), disodium EDTA (0.12 mg), polysorbate 80 (0.70 mg), and sodium chloride (5.48 mg) in Water for Injection, USP.n
  • The prefilled syringe contains an outer rigid plastic needle shield attached to an inner needle cover. The syringe or needle shield components are not made with natural rubber latex.n
  • No data
  • Long-term animal studies to evaluate the carcinogenic potential of KINERET were not conducted. KINERET had no effects on fertility and reproductive performance indices in male and female rats subcutaneous doses up to 200 mg/kg/day (approximately 25 times theMRHD on a mg/kg basis).n
  • No data
  • No data
  • KINERET is supplied in single-use preservative free, prefilled glass syringes with 29 gauge needles. Each prefilled glass syringe contains 100 mg of anakinra per 0.67 mL. The full syringe contains 100 mg anakinra. KINERET is dispensed in a 4 x 7 syringe dispensing pack containing 28u00a0syringes (NDC 66658-234-28). KINERET is also dispensed in a 1 x 7 syringe dispensing pack containing 7 syringes (NDC 66658-234-07).n
  • Storage
  • KINERET should be stored in the refrigerator at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F). Protect from light.n
  • Rx only
  • Advise the patient to read the FDA-approved patient labeling ( and ).n
  • Instruct patients and their caregivers on the proper dosage and administration of KINERET and provide all patients with the u201cPatient information and Instructions for Useu201d insert. While this Patient Information and Instructions for Use provides information about the product and its use, it is not intended to take the place of regular discussions between the patient and healthcare provider. The ability to inject subcutaneously should be assessed to ensure proper administration of KINERET. Thoroughly instruct patients and their caregivers on the importance of proper disposal and caution against the reuse of needles, syringes, and drug product. A puncture-resistant container for the disposal of used syringes should be available to the patient. The full container should be disposed of according to the directions provided by the healthcare provider.n
  • Infections: Inform patients that KINERET may lower the ability of their immune system to fight infections. Advise patients of the importance of contacting their doctor if they develop any symptoms of infection.n
  • Injection-site reactions: Physicians should explain to patients that almost a quarter of patients in the clinical trial experienced a reaction at the injection site. Injection-site reactions may include pain, erythema, swelling, prurities, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, and hemorrhage. Inform patients or their caregivers that the prefilled syringe should be removed from refrigeration and left at room temperature for 30 minutes before injecting. Patients should be cautioned to avoid injecting into an area that is already swollen or red. Any persistent reaction should be brought to the attention of the prescribing physician.n
  • Allergic or other drug reactions: Inform patients about the signs and symptoms of allergic and other adverse drug reactions and the appropriate actions they should take if they experience any of these signs and symptoms. Inform patients with DIRA and their caregivers, that DIRA patients may have an increased risk of allergic reactions, particularly in the first several weeks of treatment and they should be monitored closely.n
  • sobiSWEDISH ORPAHN BIOVITRUM
  • Manufactured by
  • U.S. License No. 1859n
  • u00a9 Swedish Orphan Biovitrum AB (publ). All rights reserved.n
  • The product, its production and/or its use may be covered by one or more US Patents, including US Patent Nos. 6,599,873 and 6,858,409 as well as other patents or patents pending.n
  • No data
  • Instructions for Use
  • Kineretn- Arrayn- (KIN-eh-ret)
  • (anakinra)
  • injection, for subcutaneous use
  • Read this Instructions for Use before you start using Kineret and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.n
  • Supplies you will need to give your Kineret injection: See .
  • Each Kineret dose comes in a prefilled glass syringe. There are 7 syringes in each new Kineret box, 1 for each day of the week. Use a new Kineret syringe each day. Use the Kineret prefilled syringe that matches the day of the week until all 7 syringes are used.n
  • Setting up for your injection:
  • Step 1
  • Step 2.
  • Step 3.n- See .
  • If the expiration date has passed, use the syringe. Call your pharmacist or call 1-866-773-5274 for assistance.n
  • Step 4.
  • Make sure the liquid medicine in the prefilled syringe is clear and colorless. It is normal to see a small amount of tiny particles that are white, or that you can see through. inject the medicine if it is cloudy or discolored, or has large or colored particles. Call your healthcare provider or pharmacist if you have any questions about your Kineret prefilled syringe.n
  • Step 5.
  • Step 6.
  • Preparing your correct dose of Kineret:
  • Selecting and preparing the injection site:
  • Step 7.n- See .
  • Recommended injection sites for adults and children include:n
  • Choose a new site each time you use Kineret. Choosing a new site may help avoid soreness at 1 site. Do not inject Kineret into an area of skin that is tender, red, bruised, swollen, or hard. Avoid areas of skin with scars or stretch marks. Do not inject Kineret close to a vein that you can see under the surface of your skin. n
  • Giving your injection:
  • Arrayn- Array
  • Step 9.n- . See .
  • Step 10.n- See n
  • Step 11.n- See .
  • Step 12.n- See .
  • Important Information about your Kineret prefilled syringe:
  • Disposal of your Kineret syringes:
  • This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.n
  • sobiSWEDISH ORPHAN BIOVITRUM
  • Manufactured by:
  • u00a9 Swedish Orphan Biovitrum AB (publ). All rights reserved. Revised Date: 12/2020n
  • Principal Display Panel - Carton Labeln
  • 4 x 7 Syringe Dispensing Packs (28 x 100 mg/0.67 mL Prefilled Glass Syringes) NDC 66658-234-28n
  • sobi
  • Kineretu00ae (anakinra)
  • Injectonn
  • 100 mg/0.67 mL
  • Single Use: Discard Any Unused Portionn
  • Subcutaneous Use Onlyn
  • Graduated Prefilled Glass Syringes with 29 Gauge Needlesn
  • Sterile Solution - No Preservativen
  • Manufactured by Swedish Orphan Biovitrum AB (publ)n
  • SE-112 76 Stockholm, Swedenn
  • License # 1859 Onlyn
  • Principal Display Panel - Carton Labeln
  • (Seven x 100 mg/0.67 mL Prefilled Glass Syringes) NDC 66658-234-07n
  • sobi
  • Kineretu00ae (anakinra)
  • Injectonn
  • 100 mg/0.67 mL
  • Single Use: Discard Any Unused Portionn
  • Subcutaneous Use Onlyn
  • Graduated Prefilled Glass Syringes with 29 Gauge Needlesn
  • Sterile Solution - No Preservativen
  • Refrigerate at 2 to 8C (36 to 46F). Do Not Freeze or Shake.n
  • Protect from Light.n
  • Rx Onlyn
  • Manufactured by Swedish Orphan Biovitrum AB (publ)n
  • SE-112 76 Stockholm, Swedenn
  • License # 1859n

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of anakinra (Kineret) which is also known as Kineret and Manufactured by Swedish Orphan Biovitrum AB (publ). It is available in strength of 100 mg/.67mL.

anakinra (Kineret) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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