About Biocon Biocon's Products & Services Research & Development Biocon's Technology Investors Media Careers CSR
  > PRODUCTS & SERVICES
  Biosimilars
  Small Molecules
  Branded Formulations
  Research Services
   
   Home
   
     
 

Biopharmaceuticals

Branded Formulations

- Immunotherapy

 

  [PA] - Patient Assistance
 

 

ALZUMAb


What is it?
ALZUMAb (also known by its generic name itolizumab) is a ‘first in class’ biologic, a humanized recombinant anti-CD6 monoclonal antibody for the treatment of patients with active moderate to severe chronic plaque psoriasis.

How does it work?
Itolizumab has a novel mechanism of action, different from that of TNFα or IL inhibitors.

Itolizumab is an anti-CD6 monoclonal antibody of immunoglobulin (Ig) G1 isotype that targets the SRCR1 (Scavenger Receptor Cysteine Rich) domain of CD6. The CD6 antigen is expressed primarily on T-cells, and is responsible for T cell maturation, activation and pro-inflammatory cytokine production. Itolizumab modulates CD6-mediated T cell co-stimulation, inhibits T-cell proliferation and inflammatory cytokine production.

Who can take it?
ALZUMAb is prescribed for adults with active moderate to severe psoriasis, who are candidates for systemic therapy.
WHO SHOULD NOT TAKE IT

  • Pediatric patients <18 years old
  • Patients with hepatic and renal impairment
  • People with active infection or with history of recurrent infection.
  • The impact of ALZUMAb is not known in pregnant women, nor is it known whether the medication passes into breast milk in nursing women. If you are pregnant or planning to become pregnant, talk to your doctor.

NOTE: Studies in special population have not been conducted

How is it used?
ALZUMAb is given by infusion, and the recommended dose is 1.6 milligrams of drug per kilogram of body weight. Seven infusions are given in a doctor’s office or infusion center during the first three months of treatment (twice a month), followed by once a month for next three months (total ten infusions). ALZUMAb should be administered in 250 mL of 0.9% saline. During infusion, the medication must be administered over a period of not less than 2 hours. The infusion period can be extended up to 8 hours for medical reasons, under the guidance and supervision of a physician. The diluted infusion solution should be prepared by a trained medical professional using aseptic technique. Prior to initiating and periodically during therapy, patients should be evaluated for active tuberculosis (TB) and tested for latent infection.

Can it be used with other treatments?
ALZUMAb is prescribed by itself. Combination therapy
with other systemic medications like methotrexate,
phototherapy, topical therapy or analgesics has not
been studied. Talk to your doctor about other
medications that you may be taking.

SIDE EFFECTS
The most common side effects are:
Infusion reactions
Upper respiratory infections
Pyrexia
Pruritus
Diarrhea

These side effects were generally mild and did not cause most patients to stop taking itolizumab. These happen most often after the first dose and may decrease after additional doses

EFFECTIVENESS

Psoriasis severity score

• Usually determined by examining the degree of redness, shedding, plaque thickness and affected body surface area. Some scores take into consideration itching and the effect that the disease has on quality of life.

• In clinical trials, 71 out of 88 patients taking the recommended dose saw clinically meaningful improvement in psoriasis severity scores (PASI 50) after 6 months.

Arthritis severity score

• Usually determined by examining swelling in and around the joints and taking into consideration joint tenderness, pain, physical function and morning stiffness.

• In clinical trials, nearly 9 out of 11 patients achieved 50 percent improvement in arthritis severity scores after 3 months.


RISKS


ALZUMAb has a good safety profile with low incidence of infection in psoriasis.

ALZUMAb is not recommended for

  • Someone with an active infection or a history of recurring infections. Tell your doctor if you have a fever, cough, flu-like symptoms, feel very tired, or have warm, red, or painful skin.

  • People should be evaluated for latent TB infections by getting a TB skin test prior to treatment with ALZUMAb. Doctors may also order a chest X-ray before starting treatment. Hidden TB must be treated before one can begin taking ALZUMAb.

  • There is a risk of developing an allergic reaction to this drug. Signs of a serious allergic reaction include a skin rash, a swollen face, or difficulty in breathing. Tell your doctor if you have any of these signs.

PATIENT ASSISTANCE INFORMATION

Please refer to Package Insert for complete information on the product.

Medical Advisor, Biocon Limited, Semicon Park, Tower II, Electronic City Phase II, Bangalore-560100.

To report adverse effects call

Toll free number 1800 102 9465 or
e-mail at DrugSafety@biocon.com






    Top
 
 
 
 
 
     
  Biocon

Businesses

Recommended sites Biocon on  
  Home
About Us

Investor Relations
Media Relations
Careers
Site Map
Contact Us
Our Growth Accelerators
Fact Sheet
Branded Formulations
Biopharmaceuticals
Research Services
Active Discovery Program

ABLE
Karnataka Vision Group on BT
Syngene International
Biocon Academy

    Linked In   
       
  Report adverse event/side effects and product complaints    
       
  * Disclaimer            © 2016, Biocon. All Rights Reserved