Palovarotene (oral route)

Sohonos

Palovarotene is used to reduce the amount of new heterotopic ossification (bone forms in the soft tissues) in patients with fibrodysplasia ossificans progressiva (FOP). This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of palovarotene in female children 8 years of age and older and in male children 10 years of age and older. Safety and efficacy have been established. However, this medicine is not recommended for use in female children younger than 8 years of age and in male children younger than 10 years of age. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of palovarotene in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and adjustment in the dose for patients receiving this medicine. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: