View Indications and Important Safety Information

IMPORTANT SAFETY INFORMATION
Contraindications:

  • You should not be administered PROLARYN GEL or PROLARYN PLUS if you have any outside objects in your throat or any pain, redness or swelling in the throat due to any throat irritation, injury or infection.
  • Before your physician injects PROLARYN GEL or PROLARYN PLUS, you should tell your doctor if you have an infection, cancer and any medical conditions that may involve your throat or upper respiratory tract.
  • You should not be administered PROLARYN GEL or PROLARYN PLUS if you have been diagnosed with paralysis of the vocal fold on both sides of your throat or if your voice disorders are caused by psychological or emotional causes.

INDICATIONS

  • PROLARYN GEL is an injectable implant used in the vocal folds to treat vocal fold insufficiency. The gel mixture disappears within 3-6 months and is a temporary implant.
  • PROLARYN PLUS is an injectable implant used to treat vocal fold insufficiency.

Injection with PROLARYN GEL or PROLARYN PLUS augments or bulks up the displaced or damaged vocal fold so that it can improve speaking. If you have serious difficulties with liquids and/or foods reaching your lungs (aspiration), you may be a candidate for immediate injection.

Warnings and Precautions:

  • PROLARYN GEL should be administered by a trained ear, nose and throat doctor who specializes in treatments of the voice box (larynx) such as an otolaryngologist or an experienced head and neck surgeon.
  • PROLARYN GEL and PROLARYN PLUS should not be injected into blood vessels. Injection into blood vessels may cause a blockage leading to serious side effects that can be life threatening. Do not over-inject the vocal fold. In extreme cases site rupture may occur if your vocal folds are over-injected by your physician.
  • Before you take PROLARYN GEL or PROLARYN PLUS, you should tell your doctor if you have had multiple surgeries as you may not be an appropriate candidate for bulking injection treatment. The product must be injected into healthy tissue to work. The product may not adhere appropriately to scar tissue and injured tissue from previous surgeries.
  • PROLARYN GEL and PROLARYN PLUS may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have trouble swallowing or breathing any time after treatment with PROLARYN GEL or PROLARYN PLUS. Treatment with PROLARYN GEL or PROLARYN PLUS can block your airway immediately after treatment and up to 7 days following injection. This can occur from aggressive vocal fold injection, over-injection of the vocal fold or swelling of the throat due to injury of the voice box (larynx) during the injection procedure.
  • For PROLARYN PLUS, therapy should be delayed at least 6 months following the onset of vocal fold paralysis and/or until an adequate trial of voice therapy or rehabilitation has been made.
  • For PROLARYN PLUS, some injectable implants have been associated with hardening of the tissues at the injection site, movement of particles from the injection site to other parts of body and/or allergic or autoimmune reactions.
  • For PROLARYN GEL and PROLARYN PLUS, the injection procedure and the associated surgical instruments used have a small but inherent risk of infection and/or bleeding.
  • For PROLARYN GEL, lack of effect is possible. In some cases, initial treatment may not work and additional injections are not beneficial.

Also, tell your doctor if you are pregnant or plan to become pregnant. (It is not known if PROLARYN GEL or PROLARYN PLUS can harm your unborn baby.)

The following adverse events were received from post-marketing surveillance for PROLARYN PLUS: infection, over-injection/under-injection, ineffective treatment, tissue displacement, exposed material, superficial injection, edema, pain, stiffness at injection site and extraction of material.

Please see Instructions for Use for PROLARYN GEL and PROLARYN PLUS or call Merz Customer Service at 866-862-1209

INDICATIONS MORE