Epcoritamab

Buy Epcoritamab (Tepkinly / Epkinly) Online in India
Generic Name/API:Epcoritamab-bysp
Packaging:Tepkinly / Epkinly is a clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous injection. It is available as a single-dose vial per carton in the following strengths: 4 mg/0.8 mL, 48 mg/0.8 mL.
Storage:Store in the refrigerator at 2° to 8°C (36°F to 46°F).
Dosage:For dosage information, please visit the General Information section.
Strength:Injection:4 mg/0.8 mL, 48 mg/0.8 mL in a single-dose vial
Indication:Tepkinly / Epkinly is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and in relapsed or refractory follicular lymphoma (FL).

Tepkinly / Epkinly (Epcoritamab) is a bispecific CD20-directed CD3 T-cell engager indicated for the following:

  1. Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. 
  2.  In combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). 
  3. As monotherapy for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy. 

Strength:

Injection: 4 mg/0.8 mL, 48 mg/0.8 mL in a single-dose vial.

Dosage: 

DLBCL and High-grade B-cell Lymphoma

Cyclea Day of treatment Dose of Tepkinly / Epkinly
Cycle 1
 1 Step-up dose 1 0.16 mg
8 Step-up dose 2 0.8 mg
15 First full dose 48 mg
22 48 mg
Cycles 2 and 3 1, 8, 15 and 22 48 mg
Cycles 4 to 9 1 and 15 48 mg
Cycle 10 and beyond 1 and 15 48 mg

aCycle = 28 days

Tepkinly / Epkinly as Monotherapy for FL

Cyclea Day Dose of Tepkinly / Epkinly
Cycle 1
 1 Step-up dose 1 0.16 mg
8 Step-up dose 2 0.8 mg
15 Step-up dose 3 3 mg
22 First full dose 48 mg
Cycles 2 and 3 1, 8, 15 and 22 48 mg
Cycles 4 to 9 1 and 15 48 mg
Cycle 10 and beyond 1 and 15 48 mg

aCycle = 28 days

Tepkinly / Epkinly in combination with Lenalidomide and Rituximab for FL

Cyclea Day Dose of Tepkinly / Epkinly
Cycle 1
 1 Step-up dose 1 0.16 mg
8 Step-up dose 2 0.8 mg
15 Step-up dose 3 3 mg
22 First full dose 48 mg
Cycles 2 and 3 1, 8, 15 and 22 48 mg
Cycles 4 to 12 1 48 mg

aCycle = 28 days

Adverse effects:

  • Cytokine Release Syndrome (CRS)
  • Injection site reactions, 
  • Fatigue, musculoskeletal pain,
  • Fever, 
  • Diarrhea
  • COVID-19
  • Rash 
  • Abdominal pain. 

Storage:

Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep in the original carton to protect from light. Do not freeze. Do not shake. 

  1. Cytokine Release Syndrome (CRS): The most common symptoms of CRS are pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions included headache, confusional state, tremors, dizziness, and ataxia. 
  2. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): The most common symptoms of ICANS are confusional state, lethargy, tremor, dysgraphia, aphasia, and non-convulsive status epilepticus. ICANS are not limited to these symptoms alone.
  3. Infections: Epkinly can cause infections such as pneumonia, COVID-19, opportunistic infections and upper respiratory infections. The most common opportunistic infections of any grade were Cytomegalovirus (CMV) infection and herpesvirus infection. 
  4. Cytopenias: Epkinly can cause serious or severe cytopenias, including neutropenia, lymphopenia, anemia, and thrombocytopenia.

Process to Import Tepkinly / Epkinly (Epcoritamab)

FAQ

Tepkinly / Epkinly (Epcoritamab) is a prescription immunotherapy used to treat certain types of B-cell non-Hodgkin lymphoma in adults. Depending on the applicable product label, it may be prescribed for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), either alone or in combination with other medicines.

Epcoritamab is a bispecific antibody that targets CD20 on B cells and CD3 on T cells. It brings these immune cells close together, helping activate T cells to recognise and attack CD20-positive lymphoma cells.

Epcoritamab is used for selected adults with relapsed or refractory DLBCL and follicular lymphoma. Depending on the approved product label, it may be used as a single medicine or with lenalidomide and rituximab for follicular lymphoma. Treatment suitability depends on the lymphoma subtype and previous therapies.

Tepkinly / Epkinly is administered as a subcutaneous injection, usually into the abdomen or thigh, by a qualified healthcare professional. Treatment begins with smaller step-up doses before the full dose to reduce the risk of cytokine release syndrome (CRS). The dosing schedule depends on the lymphoma type and prescribed treatment regimen.

Epcoritamab injection is available in two single-dose vial strengths:

  • 4 mg/0.8 mL
  • 48 mg/0.8 mL

The 4 mg/0.8 mL vial is used for preparation of the initial step-up doses, while the 48 mg/0.8 mL vial provides the full dose. Preparation and administration must be performed by trained healthcare professionals.

Common side effects may include cytokine release syndrome (CRS), injection-site reactions, fatigue, fever, muscle and bone pain, diarrhoea, rash and abdominal pain. When used with lenalidomide and rituximab, other reactions such as constipation, upper respiratory tract infections and pneumonia may also occur.

Important risks include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), serious infections and low blood-cell counts. Symptoms such as fever, chills, breathing difficulty, dizziness, confusion, difficulty speaking or unusual drowsiness need prompt medical attention. Patients should follow their treating team’s emergency instructions.

Patients may require regular blood tests to monitor blood-cell counts and check for signs of infection or other treatment-related complications. Healthcare professionals also monitor temperature, blood pressure, oxygen levels and neurological symptoms, particularly during the initial step-up dosing period. The monitoring plan depends on the patient’s condition and treatment schedule.

Tepkinly / Epkinly injection should be stored in a refrigerator at 2°C to 8°C. Keep the vial in its original carton to protect it from light. Do not freeze or shake the medicine. Follow the storage and handling instructions supplied with the specific product.

The price of Epcoritamab (Tepkinly / Epkinly) in India may vary depending on the strength, product source, availability and applicable import-related costs, where relevant. Contact 24/7QualityMeds at +91 99679 79080 to enquire about the latest price and product availability.

Patients searching for Tepkinly / Epkinly in India can contact 24/7QualityMeds to enquire about current product availability, pricing and applicable supply requirements. Availability is subject to the relevant prescription and regulatory requirements. Patients should confirm the product and supply details before proceeding.

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