Introduction of Besponsa 1 mg Injection

• Besponsa 1 mg Injection is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa 1 mg Injection is not recommended for use in pediatric patients due to safety and efficiency have not been established.
  
  Besponsa 1 mg Injection may cause some common adverse effects such as thrombocytopenia (low level of platelets), neutropenia (low level of neutrophils, a type of white blood cell), infection, anaemia (low levels of red blood cells), leukopenia (low level of a number of circulating neutrophil granulocytes), fatigue, haemorrhage, Pyrexia (fever), Nausea (feeling sick), headache, febrile neutropenia (fever in concomitance with a level of neutrophils, a type of white blood cell), transaminases increased (liver damage), abdominal pain, gamma-glutamyltransferase increased (high level of liver enzymes), hyperbilirubinemia (high levels of bilirubin, a substance made by the Breakdown of red blood cells), serious adverse reactions, etc. If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them.
  
  Besponsa 1 mg Injection is not recommended for use in allergy to Besponsa 1 mg or to any of the excipients. Besponsa 1 mg Injection is also not recommended for use in Patients with serious ongoing hepatic disease (ex: cirrhosis, nodular regenerative hyperplasia, active hepatitis and Patients who have ongoing VOD/SOS condition (Veno-occlusive disease (VOD), which is also called sinusoidal obstruction syndrome (SOS), happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
  
  Before taking Besponsa 1 mg Injection, inform your doctor if you have a medical history of bleeding disorders, heart or liver disease, radiation treatment, or any other infection. Many other medicines can affect, or be affected by, this medicine, so let your doctor know about all the medications you are using. Inform the doctor immediately if you notice unusual bruising or bleeding, have dark, tarry, or bloody stools, and sore throat. This medicine reduces the number of blood cells in your blood, thereby increasing susceptibility to infections. Regular blood tests are required to check your blood cells along with the kidney, liver, and heart function during the treatment with this medicine. Effective contraception by males and females during the treatment with this medicine is important to avoid pregnancy.
  
  Besponsa 1 mg Injection is administered by a healthcare professional or nurse in a hospital or clinic setting. The specific dosing and administration of Besponsa 1 mg Injection will depend on the clinical condition of the patient's age and medical history and other factors. Kindly do not self-administer.
  

Uses of Besponsa 1 mg Injection

• • Treatment of Acute lymphoblastic leukaemia (Blood cancer)
    

Benefits of Besponsa 1 mg Injection

• Acute lymphoblastic leukemia (Blood cancer): Acute lymphoblastic leukemia (ALL) is a cancer of the lymphoid line of blood cells characterized by the development of large numbers of immature lymphocytes. Symptoms may include feeling tired, pale skin color, fever, easy bleeding or bruising, enlarged lymph nodes, or bone pain. Besponsa 1 mg Injection kills or stops the growth of cancer cells and prevents the multiplication of cancer cells. It is a potent and very toxic medicine, and you should discuss its risks and benefits with your doctor. Avoid drinking alcohol during the treatment with this drug and drink plenty of water to stay hydrated.
  

Side Effects of Besponsa 1 mg Injection

• ​​​Like all medications, Besponsa 1 mg Injection can cause side effects but do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them.​​
  

Most Common Side Effects of Besponsa 1 mg Injection

• • Low blood count
  • Fatigue
  • Nausea
  • Rise in Liver enzymes
  • Wheezing
  • ​Headache
  • Chills
  • Nosebleed
  • Vomiting
  • Anorexia
  • Constipation
  • Yellow skin
  • Tiredness
  • Dark Urine​
    

Common Side Effects of Besponsa 1 mg Injection

• • occlusive Disease
    
  • Bleeding
  • High Fever
  • Shortness of Breath
  • Closing of Throat
  • Difficult Breathing
  • Frequent Diarrhea
  • Hematuria
  • Painful and Swollen Mouth ulcers
  • Painful and burning urination

How to Use Besponsa 1 mg Injection?

• Besponsa 1 mg Injection is given by a trained doctor or nurse at a hospital or clinical setting. Do not self-administer the Besponsa 1 mg Injection. Your doctor will decide the dose and duration of your treatment based on the disease severity and other factors. It will be given as an intravenous infusion, and you will be monitored carefully for unwanted side effects.
  

How Besponsa 1 mg Injection Works?

• Besponsa 1 mg Injection contain an active substance called inotuzumab ozogamicin, which is a monoclonal antibody (a type of protein) that has been linked to a small molecule - N-acetyl-gamma-calicheamicin dimethyl hydrazide - a cytotoxic agent that once activated provokes the death of cancer cells. The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells. Once attached, the medicine is taken up by the cell where the cytotoxic agent becomes active, causing breaks in the cell’s DNA and thereby killing the cancer cell
  

Safety Advices Besponsa 1 mg Injection

Liver

Safe

Besponsa 1 mg Injection is safe to use in patients with liver disease. No dose adjustment of Besponsa 1 mg is recommended.

Alcohol

Unsafe

It is generally not recommended to drink alcohol while taking Besponsa 1 mg Injection. It may increase the risk of liver damage. it is best to avoid alcohol or limit your alcohol consumption while taking any medication.

Kidney

Use with Caution

Besponsa 1 mg Injection is safe for use in mild, moderate or severe kidney disease patients. No adjustment to the starting dose is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CLcr] 60-89 mL/min, 30-59 mL/min, or 15-29 mL/min. The safety and efficacy of Besponsa 1 mg have not been studied in patients with end-stage renal disease.

Pregnancy

Unsafe

Use of Besponsa 1 mg Injection may be unsafe during pregnancy as animal studies indicate that it may harm the developing foetus. However, if you are pregnant or planning to become pregnant, it is important to talk to your doctor about the potential risks and benefits of taking Besponsa 1 mg during pregnancy. Your doctor will be able to help you make the best decision for you and your baby's health.

Breastfeeding

Unsafe

It is not recommended to breastfeed while taking Besponsa 1 mg. Besponsa 1 mg Injection may pass into breast milk and harm the infant. If you are breastfeeding and taking Besponsa 1 mg Injection, it is important to talk to your doctor about the possible risks and benefits of continuing to breastfeed. Your doctor will be able to help you make the best decision for you and your baby's health.

Driving

Use with Caution

Besponsa 1 mg Injection has moderate influence on the ability to drive and use machines. Patients may experience fatigue during treatment with Besponsa 1 mg. Therefore, caution is recommended when driving or operating machines.