Blincyto : Uses, Side effects, and Interactions

Overview

What is Blincyto?

The generic name for Blincyto is blinatumomab. This pharmaceutical agent is classified as a CD19 monoclonal antibody.¹Overview| Researched based study from Dailymed.nih.gov

The production process of Blincyto involves the utilization of recombinant DNA technology in Chinese hamster ovary cells. It is manufactured by a Chinese company known as Amgen Inc.

Blincyto aka Blinatumomab is regarded as a specific anti-cancer medication. It is utilized as a form of therapy to treat patients plagued with a specific subtype of acute lymphoblastic leukemia (ALL) known as pre (precursor) B cell ALL.

What is ALL?

• ALL is a type of blood cancer which begins from WBC (lymphocytes) originating from the bone marrow. It is one of the commonest leukemia that affects children.

Let us get the lowdown on the medicine that’s been shown effective against acute lymphoblastic leukemia.

Composition

Composition of Blincyto

The ingredients in Blincyto are

Active ingredient

• Blinatumomab

Inactive ingredients

• Lysine hydrochloride
• Citric acid monohydrate
• Trehalose dihydrate
• Polysorbate 80
• Sodium hydroxide
• Preservative-free sterile water for injection.²Composition| Researched based study from Nlm.nih.gov

Uses

Uses of Blincyto

Treatment of Acute lymphoblastic leukemia

• The US Food and Drug Administration (FDA) granted approval for Blincyto.³Uses| Researched based study from Fda.gov
• Blinatumomab, marketed as Blincyto, is a biopharmaceutical agent used as an added treatment for Acute lymphoblastic leukemia (ALL).
• Blinatumomab is a monoclonal antibody ⁴Uses| Researched based study from Cancer.gov that involves specific targeting of a protein present on leukemia cells. This will improve the capability to identify cells by interacting with the immune system. The immune system will eliminate leukemic cells via targeted attack and destruction.

How to use Blincyto?

• Blincyto is administered intravenously. The administration of the medication is prescribed as a constant dosage for a duration of approximately 28 days per cycle.
• The therapeutic intervention could involve the introduction of an expanded plastic catheter into a significant venous structure situated in the thorax. The tube remains fixed during the treatment regimen.

Dosage

Dosage of Blincyto

One Blincyto Package comprises a vial of Blincyto and a vial of IV Solution Stabiliser

• Blincyto comes in a lyophilized powder. It is sterile and devoid of preservatives. It is intended for intravenous administration and is packaged in a single-dose vial. The drug is sold in a single strength of 35 micrograms (mcg).⁵Dosage| Researched based study from Fda.gov

• The dose to be injected per cycle relies upon the weight of the patient. If the weight of the patient is >45 kg then fixed doses are given. While in patients with <45 kg, the doses are altered according to the surface area of the body. The precise dosage and regimen will be determined by the physician.

• It is advisable to undergo hospital stay during the initial 9 days of the first cycle of Blincyto infusion, as well as the first 2 days of the subsequent cycle.

• Blinatumomab is administered using an infusion pump over a period of 28 days, followed by a 2 week break. The physician will determine the need for additional treatment with this medication following the intermission.

• Subsequent treatment cycles may require extended intervals of rest, up to 8 weeks. Avoid changing the infusion pump controls to prevent the infusion of an incorrect dosage.

Promptly consult your healthcare provider for any inquiries regarding the infusion pump.

Infusion of Blincyto

Administer Blincyto solution at a constant infusion rate as directed on the pharmacy label of the prepared bag.

• You can administer a 24-hour infusion at a rate of 10 mL/hour or Administer at a rate of 5 mL/hour for 48 hours.

• Blincyto solution requires IV tubing with an uncontaminated, non-pyrogenic, minimal protein-binding, 0.2 micron parallel filter for administration.

• It is essential that you avoid flushing the Blincyto infusion line or intravenous catheter, particularly during the process of changing infusion bags.

• Flushing during bag changes or at the end of an infusion may lead to excessive dosing and subsequent complications. Blincyto should be embedded through an independent lumen when using a multi-lumen venous catheter.

Side effects

Side effects of Blincyto

The side effects of Blincyto include:

Anaphylactic reactions

• Blinatumomab may elicit an allergic response in certain individuals. This reaction is typically observed within the initial 48 hours of drug administration. Common symptoms consist of fever, chills, muscle pain, rash, facial swelling, or respiratory distress.

Immediately reach out to the doctor if you experience:

• Fever of more than 38°C.
• Seizures.
• Loss of consciousness.
• Inability to speak.⁶Side effects| Researched based study from Mayoclinic.org

Cytokine release syndrome

• The proteins that enhance the immune system are known as cytokines. Blincyto has the ability to induce cytokine production leading to severe symptoms. Symptoms of the condition include fever, chills, headache, dyspnea, and vertigo.

Headache

• Analgesics can be given to manage headaches.

Rashes

• Redness of the skin along with itching might be seen.

Dyspnea and pallor

• Dyspnea and pallor results from a decrease in erythrocytes. This condition is referred to as anemia.

Symptoms of bleeding

• Such as bruises, gum bleeding, or a nosebleed
• These features are seen because of reduction in platelet count.

Inflammation

• Blincyto can lead to fluid retention in various body regions, including the face, hands, and feet.

Neurological toxicity

• Approximately 65% of patients with ALL who received Blincyto experienced neurological toxicities.

Infections

• According to the clinical studies 25% of patients showed serious infections including pneumonia, fungal infections, On site Catheter infections, Sepsis etc. Few of these were even fatal.⁶Side effects| Researched based study from Mayoclinic.org

Other side effects include:

• Decrease the blood cell counts.
• Nausea.
• Weakness.
• Muscle cramps.
• Confusion.
• Unusual bleeding.
• Low potassium – constipation, increased urination, lethargy and numbness.
• Low Blood pressure.
• Cough
• Low levels of even a problem.
• Difficulty sleeping
• Weight gain.
• Seizures.

Serious side effects may occur in individuals using this medication. The drug has been prescribed based on a risk-benefit analysis done by your doctor. Close supervision by a medical professional can lower the likelihood of adverse outcomes.

Contraindications

Contraindications of Blincyto

You must avoid Blincyto if you are suffering from any of these:

• Recurrent infections.
• Decreased neutrophils.
• Breastfeeding
• Any disease of the white matter of the brain like leukoencephalopathy.
• Inflammation of the pancreas.
• Seizures (fits)
• Pregnancy: Due to its mechanism of action, Blincyto may result in fetal harm in the form of B-cell lymphocytopenia, if given to a pregnant woman.⁷Contraindications| Researched based study from Tga.gov.au
• It is recommended to abstain from receiving immunizations containing live vaccines for a minimum of two weeks prior to, during, and up to twelve months following treatment with Blincyto.

Interactions

Interactions with Blincyto

You must explain to your doctor about all other medications that you are using, be it prescription and non-prescription drugs, dietary supplements, and herbal remedies.

• Before initiating, discontinuing, or modifying medication dosages, you must consult your doctor.

• The maximum risk of drug-drug interactions ⁸Interactions| Researched based study from Ema.europa.eu occurs within the early 9 days of the first cycle and the early 2 days of the second cycle. It is seen in patients receiving simultaneous CYP450 substrates, especially those with a narrow therapeutic index. Potential toxicity (e.g. warfarin) or drug concentrations (e.g. cyclosporine) must be assessed in these patients.

• The potential for benzyl alcohol toxicity ⁹Interactions| Researched based study from Empr.com in young children as a result of the presence of benzyl alcohol preservative was seen. Infants who are born prematurely and have low birth weight may exhibit a higher propensity to experience such reactions owing to their potentially reduced capacity to metabolize benzyl alcohol.

Blinatumomab has interactions with the following drugs

• Ropeginterferon alfa 2b
• Sirolimus
• Carbamazepine
• Cyclosporine
• Dichlorphenamide
• Ethosuximide
• Fosphenytoin
• Ofatumumab SC
• Phenobarbital
• Phenytoin
• Primidone
• Quinidine
• Quinine
• Siponimod
• Tacrolimus
• Theophylline

Storage

Storage of Blincyto

• It is recommended to refrigerate the Blincyto and IV Solution Stabilizer vials in their original packaging at a temperature range of 2°C to 8°C (36°F to 46°F).
• You must shield them from light until the intended time of use. Never opt for freezing the Blincyto drug.
• The storage duration of Blincyto and IV Solution Stabilizer vials is limited to 8 hours at room temperature. It is stored specifically within the range of 23°C to 27°C (73°F to 81°F).
• It is recommended to keep the vials in their original carton during storage to ensure protection from light.

Precautions

Precautionary tips for Blincyto

• Consume 2-3 quarts of fluids per day, unless otherwise directed.
• To reduce bleeding, utilize an electric razor and a gentle toothbrush.
• Alcohol consumption should be limited or abstained from altogether.
• To minimize the risk of infection, avoid crowded places.
• To reduce nausea, adhere to the prescribed anti-nausea medication regimen and consume small, frequent meals.
• Minimize exposure to sunlight. Apply sunblock having atleast SPF of 30 and wear protective clothing.
• To reduce flu-like symptoms, maintain warmth through the use of blankets and increase fluid intake. Certain medications may ease chills-related discomfort.
• Acetaminophen and ibuprofen are effective in alleviating symptoms such as fever, headache, and generalized aches and pains. It is advisable to consult with a medical professional prior to consumption.

Suggestions to avoid any ill effect of Blincyto

Cytokine release syndrome

• CRS is a condition characterized by the release of cytokines. Patients should be informed about the potential hazards of CRS and infusion patterns, and advised to promptly notify their healthcare provider if they experience any symptoms related to these conditions.

Neurotoxicities

• Patients should be informed about the possibility of neurological toxicities and advised to promptly notify their healthcare provider if they experience any related clinical symptoms.

Infections

• Patients should be informed about the potential risk of infections and advised to promptly notify their healthcare provider if they experience any signs or symptoms of infection.

Pancreatitis

• Patients must be informed about the possibility of pancreatitis. They must be instructed to notify their doctor if they feel any symptoms such as nausea, persistent abdominal pain, along with vomiting.

Operating Vehicles and Risky Professions

• Patients should avoid driving, hazardous occupations, and operating hefty or possibly hazardous machinery while receiving Blincyto treatment.

Takeaway

Key Takeaways

• Blincyto is a treatment option for acute lymphoblastic leukemia (ALL) that may be of interest to those seeking treatment options.
• Full recovery rates with the use of usual salvage chemotherapy is found to be 30-40% in first relapse and 20-25% in second relapse.
• This medication is prescribed to treat acute lymphoblastic leukemia (ALL) in adults and some children.
• Acute lymphoblastic leukemia (ALL) is a rapidly progressing hematological malignancy. Untreated ALL can result in fatality within a few months.
• Blincyto is not a form of chemotherapy. Blincyto is a substitute cancer treatment that works via an independent system. Chemotherapy is a therapeutic modality that removes or blocks the growth of cancerous cells.
• Chemotherapy lacks specificity, leading to the destruction of both malignant and non-malignant cells. This may result in numerous adverse effects. Blincyto is used for targeted therapy as a monoclonal antibody. Unlike chemotherapy, it exhibits selective cytotoxicity towards cancer cells.