MEDICAL INFORMATION FOR HEALTH CARE PROFESSIONALS

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T-20 (PENTAFUSIDE)

Other names: Pentafuside, RO 29-9800

WHY is this medication prescribed?

T-20 is an investigational drug only available to people enrolled in clinical trials.  This medication belongs to a new class of drugs called fusion inhibitors. 

T-20 is an antiretroviral medication that interferes with the human immunodeficiency virus (HIV) ability to enter CD4 cells.  As a result the virus cannot get into cells to replicate, which may slow the progression of the disease.  T-20 does not cure HIV nor does it prevent HIV transmission.  Since it has not been determined how the effect of T-20 progresses over time, it is important that your doctor assesses your progress regularly.  It is currently not known how long the beneficial effects of this medication will last.

HOW should this drug be taken?

The drug is supplied as a 106mg/3.5mL vial.  The powder in each vial has to be mixed with the supplied sterile water for injection.  The instructions for mixing and injection are as follows:

  • Assemble supplies on a clean surface
  • Wash your hands thoroughly
  • Clean the tops of all vials with an alcohol swab
  • Draw up 1.1mL of sterile water using the safety syringe & needle
  • Slowly inject sterile water into the T-20 vial, letting water flow down the side of the vial
  • Discard the needle in a biohazard container
  • Mix the T-20 powder with the water by rolling or tapping the vial (Do NOT shake); it takes 2 to 5 minutes for the powder to dissolve
  • Draw up T-20 for your injection into a new safety syringe & needle.
  • Eliminate air bubbles from syringe and ensure 1.0mL is in the syringe
  • Choose a place on your body for injection (Do NOT select same site as your last injection) & then give yourself the injection
  • Throw away your used supplies (needles in the biohazard container), but keep all T-20 vials as they need to be returned to your physician's office.

T-20 is meant to be taken in combination with other antiretroviral medications. 

The usual regimen is 90mg injected twice daily (ideally every 12 hours)

Your regimen is:

 

What should you do if you FORGET a dose?

If you miss a dose of T-20, take it as soon as possible, then just carry on with your regular dosing schedule.  If you remember your missed dose close to time for your next dose, do not double your dose.  Continue with your regular dosing schedule.

What SIDE EFFECTS can this drug cause?  What should you do about them?

The most common side effect of T-20 (~66%) is injection site reactions.  This reaction is generally 2 cm (3/4") in diameter and can maybe sore, red, itch, have burning sensation, bruising or pain.  These reactions tend to improve over the 1st few days but it may take up to 3 weeks to completely disappear.  In most cases, the drug can be continued.  However, if you have a severely painful or discomforting reaction, you should discuss this with your health care team. 

Other side effects which may be associated with the use of T-20effects that may be associated with the use of T-20 include diarrhea, nausea, vomiting, dizziness, difficulty sleeping, headache, racing heart beat, skin discoloration or reddening, abdominal pain, weakness, and fever.  Rare but more serious reactions which have resulted in patients being hospitalized have also been reported in clinical trials.

IF YOU ARE EXPERIENCING ANY ADVERSE EFFECTS, PLEASE DISCUSS THEM WITH YOUR HEALTH CARE TEAM.

IT IS IMPORTANT THAT YOU KEEP YOUR REGULAR DOCTOR'S APPOINTMENTS, SO THAT YOUR PROGRESS CAN BE ASSESSED.

What other precautions should you follow while using the drug?

T-20 does not appear to have a high risk of interacting with other drugs you are taking.  However, it is still important that your physician and pharmacist know about other drugs you are taking, even medications you can buy without a prescription.  This is important since some medications are not permitted or discouraged during the T-20 trial.  Examples of medications that are not permitted or discouraged during the T-20 trial are:

  • IL-2, interferons, Ampligen, HIV Vaccine, some investigational antiretroviral drugs (including adefovir and MKC-442), investigational drugs for other conditions
  • St. John's Wort, hydroxyurea

The safety of T-20 has not been established during pregnancy or breast feeding.  Please discuss this with your doctor or pharmacist if this is a concern.

How should this medication be STORED?

Store T-20 vials in the fridge (2 to 8 C).  The powder is stable for approximately 6 months in the fridge.  However, once you have mixed the powder with the water, the reconstituted solution is stable for only 2 hours.  Keep well out of the reach of children.

IF YOU HAVE ANY QUESTIONS OR CONCERNS ABOUT THIS MEDICATION PLEASE DISCUSS THEM WITH YOUR NURSE, PHARMACIST, OR PHYSICIAN.

PLEASE WRITE DOWN YOUR QUESTIONS OR CONCERNS TO ENSURE THEY ARE ADDRESSED.

A pharmacist at The Immunodeficiency Clinic, The Toronto Hospital_________________________________, is available to answer questions. 

The telephone number is (416) 340-5077__________________________. 

Please ask for Alice__________________________________.

Adapted from the Investigator's Brochure Version 4 , October 6,  2000) Hoffman La Roche, Inc and Trimeris, Inc.  and Clinical Study Protocol (Protocol Number T20-301/NV16054 October 6, 2000)