What is Vaxira®?

Vaxira® is a biopharmaceutical product that stimulates the body to produce an immune response against lung cancer.

What are the results of the clinical experience with Vaxira®?

Vaxira® has been studied in over 1000 patients, in which it produced a stimulation of the immune system and was well tolerated. In an early study, it was observed that 71 patients with non-small cell lung cancer lived longer than usually expected for this disease when treated with Vaxira®, and in a subsequent study in 176 patients with advanced lung cancer, a higher survival rate was demonstrated in patients treated with Vaxira® compared to placebo. There are other ongoing clinical trials in patients with non-small cell lung cancer. Moreover, the effect of Vaxira® is also being investigated in pediatric tumors, where it has hitherto shown a good tolerance and immunogenicity.

Contraindications and Side Effects

You should not receive Vaxira® if you are allergic (hypersensitive) to, or have a history of being allergic to any of the chemical or biological compounds in the Vaxira® formulation.

Before you receive Vaxira® your doctor needs to know:

  • If you have or have had heart problems.
  • If you are pregnant or plan to become pregnant.
  • If you are taking oral corticosteroids.

What are the most common side effects of Vaxira®?

The most common side effects are generally mild, transient and reversible. There may be pain, redness or localized hardening of the skin surface at the injection site, fever, chills, hypotension, muscle aches, malaise, joint pain or nausea.

Note that other oncology treatments prescribed by your physician may cause side effects, which may vary according to the type of treatment indicated.

Tell your doctor if you are taking any other medications.

Pregnancy and lactation

The effect of Vaxira® on fertility in men and women is not known. Also unknown is the possible effect on an infant who is breastfeeding if the mother is receiving Vaxira®. Therefore, if you are breastfeeding, pregnant or planning to become pregnant (or your spouse is planning to get pregnant), you should not receive Vaxira®. Moreover, Vaxira® is not recommended in people who do not use an effective contraceptive method. Inform your doctor immediately if you become pregnant or think you might be pregnant, or if your spouse becomes pregnant.

How is Vaxira® administered?

Vaxira® is administered intradermally using a fine needle. Every time you receive this vaccine, each dose will be divided into 4 small injections given in 4 different sites of your body, which can be arms and legs. If 2 sub-doses need to be administered in the same area, the sites of administration should be at least 5 centimeters apart. The first 5 dose should be administered at 14-day intervals. It is very important that you follow this vaccination protocol appropriately in order to stimulate the body's defense system. After this initial 5-dose phase is completed, you will receive booster doses every 28 days, as long as it is well tolerated and you and your oncologist consider it may be beneficial. The first two times you are given the product you will be asked to remain at the medical center for an hour for observation of your immediate reaction to Vaxira®. If your disease progressed, your doctor may add other cancer treatments to the Vaxira® protocol.