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GLOFITAMAB

Glofitamab

Generic Name/API:Glofitamab
Packaging:One vial/pack
Storage:Store at 2°C to 8°C.
Dosage:For dosage information, please visit the General Information section.
Strength:Injection available in following strengths 2.5 mg/2.5 mL (1 mg/mL) in a single-dose vial 10 mg/10 mL (1 mg/mL) in a single-dose vial.
Indication:COLUMVI (glofitamab-gxbm) is indicated for the treatment of adult patients with relapsed  or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising  from indolent lymphoma, after two or more lines of systemic therapy. This indication is approved  under accelerated approval based on response rate. 

Columvi (glofitamab) is a novel bispecific antibody that targets CD20 on B cells and CD3 on T cells,  effectively directing the immune system to eliminate cancer cells. It has high efficacy in relapsed or  refractory diffuse large B-cell lymphoma (DLBCL), with strong overall and complete response rates.  Columvi offers a fixed-duration treatment regimen, providing clarity and convenience for both  physicians and patients. Approved by both the FDA and the European Commission under accelerated  pathways, it is a globally recognized option for difficult-to-treat lymphoma cases. Its step-up dosing  approach also ensures a manageable safety profile, particularly in reducing the risk of cytokine release  syndrome. 

Strength: Columvi is supplied in two strengths 2.5mg and 10mg.  

Dosage:

The recommended dosage regimen for Columvi is as follows: 

TREATMENT CYCLE  DAY  DOSE  DURATION OF  

INFUSION

Cycle 1  Day 1  Obinutuzumab
Day 8  Set-up  

dose 1

2.5mg 4hours
Day 15  Set-up  

dose 2

10mg
Cycle 2  Day 1  30mg  4 Hours
Cycle 3 to 12  Day 1  30mg  2 Hours

Storage: Store refrigerated at 2°C to 8°C, protect from light. Do not freeze. 

Adverse reaction:

The following are the adverse reactions seen with Columvi 

Cytokine release syndrome 

CRS is a condition where the body’s immune system overreacts to a trigger, leading to a rapid and  excessive release of inflammatory chemicals called cytokines. Signs of CRS includes fever, rapid  heartbeat, low blood pressure, chills, and reduced oxygen levels. In CT it was seen that CRS generally  began around 14 hours after infusion and lasted a median of 2 days, resolving in 98% of cases. The  highest incidence occurred after the initial 2.5 mg step-up dose, with decreasing frequency following  higher doses.  

Neurological disorders 

COLUMVI may cause serious and potentially fatal neurologic toxicity, including Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS). In clinical trials involving 145 patients, common  neurologic side effects included headache (10%), peripheral neuropathy (8%), dizziness or vertigo (7%),  and mental status changes (4.8%), such as confusion, disorientation, and delirium. The risk may be  increased when COLUMVI is used with other medications that cause dizziness or cognitive changes. 

Musculoskelatal pain: 

Musculoskeletal pain is a commonly reported adverse effect of COLUMVI in clinical trials. It can involve  discomfort in the muscles, joints, bones, or surrounding tissues and may manifest as general body  aches, joint stiffness, or localized pain. This type of pain is thought to be related to immune system  activation or cytokine release, both of which are known effects of COLUMVI and similar  immunotherapies. While the severity is usually mild to moderate, any persistent or worsening  musculoskeletal pain should be assessed by a healthcare provider. 

COLUMVI carries several serious risks, including cytokine release syndrome (CRS), neurologic toxicity,  infections, tumor flare, and embryo-fetal toxicity. CRS occurred in 70% of patients, with severe cases  in a small percentage; it typically starts within hours of dosing and can recur. Neurologic toxicities,  including serious events like ICANS, were reported in 4.8% of patients, with symptoms such as headaches, dizziness, and altered mental status. Serious or fatal infections, including COVID-19 and  sepsis, occurred in 16% of patients. Tumor flare, seen in 12% of patients, may lead to localized pain or  organ compression, especially in those with bulky tumors. Additionally, COLUMVI may harm a fetus;  therefore, effective contraception is required during treatment and for one month afterward. Close  monitoring and adherence to dosing protocols are essential to manage these risks. 

Process to Import Medicine

FAQ

  • What is COLUMVI used for?
  • How is COLUMVI administered?
  • What are the serious risks associated with COLUMVI?
  • Can COLUMVI be administered by pregnant or breastfeeding women?
  • What are the key criteria for selecting a supplier?
  • How do we import shipment?
  • What is the cost of Columvi (glofitamab) in India?
  • How to buy Columvi (glofitamab) in India?
What is COLUMVI used for?

COLUMVI is used to treat adults with relapsed or refractory diffuse large B-cell lymphoma  (DLBCL) after at least two prior lines of treatment

How is COLUMVI administered?

 COLUMVI is given as an intravenous (IV) infusion following a step-up dosing schedule to reduce the  risk of cytokine release syndrome (CRS). Treatment is usually done in a hospital or clinic.

What are the serious risks associated with COLUMVI?

COLUMVI can cause: 

  • Cytokine release syndrome (CRS) 
  • Neurologic toxicity  
  • Serious infections
  • Tumor flare 
Can COLUMVI be administered by pregnant or breastfeeding women?

No. COLUMVI may harm your unborn baby. Avoid pregnancy during treatment and for at least one  month after the last dose. It is also not recommended during breastfeeding.

What are the key criteria for selecting a supplier?

While selecting a supplier, we essentially ensure that the supplier holds a valid Good Distribution  Practice (GDP) certificate and posssess a valid operating license. These credentials confirm that  the suppliers adherence to International standards for the proper distribution of medicinal  product. 

How do we import shipment?

Shipments are delivered in a validated cold chain box to ensure the medication remains safe and maintains its required temperature throughout transit.

What is the cost of Columvi (glofitamab) in India?

Cost of  Columvi (glofitamab) may vary each time, as the medicine is not approved in India and must be imported. Factors such as international currency exchange rates (USD/EUR) and import duties can affect the final cost. For more details, please contact 247 QualityMeds.

How to buy Columvi (glofitamab) in India?

To buy Columvi (Glofitamab) in India at a genuine and affordable price, contact 247 Quality Meds. We help you import Columvi legally with full documentation, ensuring timely delivery and cost efficiency. Call now: 9967979080.

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