May 11, 2022

Cost, side effects, uses, method of administration, etc.

Saphnelo can cause mild or severe side effects. The following lists contain some of the main side effects that can occur with Saphnelo. These lists do not include all possible side effects.

For more information about the possible side effects of Saphnelo, talk to your doctor or pharmacist. They can give you advice on how to deal with side effects that may be concerning or bothersome.

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you have had with Saphnelo, you can do so via MedWatch.

Mild side effects

Mild* side effects of Saphnelo may include:

Most of these side effects may disappear within a few days to a few weeks. However, if they get worse or don’t go away, talk to your doctor or pharmacist.

*This is a partial list of mild Saphnelo side effects. For more information about other mild side effects, talk to your doctor or pharmacist, or check the prescribing information.
† For more information on this side effect, see “Details of side effects” below.

Serious side effects

Serious side effects from Saphnelo are not common, but they can occur. Call your doctor right away if you experience any serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

Serious* side effects of Saphnelo may include:

* For more information on these side effects, see ‘Details of side effects’ below.

Details of side effects

Here are some details about some side effects that this drug can cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Saphnelo.

Infection

Saphnelo can increase the risk of infection. The drug works by weakening your immune system, which is your body’s defense against infections. If your immune system is not strong, you may develop an infection more easily than usual. Most infections experienced by people receiving Saphnelo clinical tests were sweet. Examples include the common cold and other upper respiratory infections.

However, Saphnelo can cause more serious, potentially life-threatening infections. Serious respiratory infections that have occurred with the drug include bronchitis and pneumonia. Saphnelo can also increase the risk of shingles.

what you can do

You should be aware of possible symptoms of infections, such as:

If you develop symptoms of a Saphnelo infection, tell your doctor straight away. They will watch you. Your doctor may also recommend treatment such as antibiotics or steroids. An example of a steroid drug is prednisone (Rayos). The sooner the infection is treated, the better. This helps prevent the infection from getting worse.

Before you are given Saphnelo, it is important to talk to your doctor about any infections you have or have had. For more information, see the “Saphnelo Precautions” section below.

For more information about infections that may occur during treatment with Saphnelo, talk to your doctor.

Infusion-related reaction

Some people may have a reaction to Saphnelo infusions, called an infusion-related reaction. Reactions may occur during the infusion or shortly after receiving an infusion.

For most people who have had a reaction during treatment with Saphnelo in clinical tests, the reaction was mild or moderate. Mild reactions can cause symptoms such as:

Mild reactions did not cause people to stop treatment with Saphnelo.

In rare cases, Saphnelo can cause serious infusion reactions. Symptoms may include swelling of the lips, mouth, or throat. Other possible symptoms include difficulty breathing and changes in blood pressure.

You may be at increased risk of a reaction during the first 12 weeks of treatment with Saphnelo.

what you can do

To help reduce your risk of reactions with Saphnelo infusions, you may receive certain medicines before treatment, such as:

  • methylprednisolone (Solu-Medrol)
  • diphenhydramine (Benadryl)
  • acetaminophen (Tylenol)

A healthcare professional will monitor you for any symptoms of a reaction during your Saphnelo infusions. If you have mild symptoms, they may slow down or stop the infusion. They may also give you your next infusion over a longer period to help prevent symptoms.

If you develop a serious infusion-related reaction, the healthcare professional can treat it right away. Your doctor may then recommend switching from Saphnelo to another medicine.

Allergic reaction

As with most medicines, some people may have an allergic reaction after receiving Saphnelo.

Symptoms of a mild allergic reaction may include:

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction may include:

  • swelling under the skin, usually in the eyelids, lips, hands, or feet
  • swelling of the tongue, mouth or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Saphnelo, as the reaction could become serious. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.


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