BEYFORTUS

Beyfortus was approved in the European Union in October 2022 for the prevention of RSV LRTD in newborns and infants during their first RSV season and received approval by the US Food and Drug Administration in July 2023 following the unanimous recommendation by the Antimicrobial Drugs Advisory Committee in June 2023.

Nirsevimab can protect babies throughout the duration of a virus season. In clinical trials, a single injection reduced the chances of severe infection requiring medical attention by 74.5%.

Protection from Beyfortus has been shown to last through 5 months, which means one dose should last an entire RSV season. Synagis, on the other hand, doesn’t last as long in the body. Each dose lasts about 28 to 30 days, so your child will need to receive monthly doses for the duration of RSV season.

$495 per dose for 50mg and 100mg doses.

There are two RSV antibody products that can help prevent severe RSV disease in infants and young children: Nirsevimab (Beyfortus), and Palivizumab (Synagis). Nirsevimab is recommended for: All infants younger than 8 months of age born during RSV season or entering their first RSV season.

The most common side effects of BEYFORTUS include rash, and pain, swelling or hardness at the site of your child’s injection. These are not all of the possible side effects of BEYFORTUS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For children up to 24 months of age who remain at increased risk for severe RSV disease in their second RSV season, the recommended dosage of BEYFORTUS is a single 200 mg dose administered as two IM injections (2 x 100 mg).

“Beyfortus, like Synagis, is a monoclonal antibody called nirsevimab. The key difference between Synagis and Beyfortus is that the new medication is much stronger. It grabs onto RSV virus and won’t let it go. It also lasts longer.

For infants in their first RSV Season (October – March*) Give Nirsevimab (Beyfortus) based on child’s weight: 50 milligrams, 0.5mL, intramuscular (IM) for infants weighing less than 5 kg (11 pounds).

Beyfortus (nirsevimab) (5 x 0.5mL syringes) and (5 x 1.0mL syringes) is available to order through the Vaccines for Children (VFC) program starting today, October 2, 2023.

The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus™ (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age …

Each pre-filled syringe contains 50 mg of nirsevimab in 0.5 mL (100 mg/mL). Excipients: L-histidine, L-histidine hydrochloride, L-arginine hydrochloride, sucrose, polysorbate 80, water for injections.

Beyfortus starts working within hours after your child receives their dose. Beyfortus is prescribed to certain children to help prevent respiratory syncytial virus (RSV) infection.

There are two RSV antibody products that can help prevent severe RSV disease in infants and young children: Nirsevimab (Beyfortus), and Palivizumab (Synagis). Nirsevimab is recommended for: All infants younger than 8 months of age born during RSV season or entering their first RSV season.

Nivrsevimab is a monoclonal antibody that acts almost like a vaccine, training a child’s immune system to recognize RSV and defend against it. Half of the babies in the study were randomly assigned to receive nirsevimab, and half received no treatment.

The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus™ (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age …

For children up to 24 months of age who remain at increased risk for severe RSV in their second RSV season, the recommended dosage of Beyfortus is a single 200 mg dose administered as two IM injections (2 x 100 mg).

The high cost of Beyfortus, $495 a dose, and the rigid rules that govern the federal effort to distribute free shots to kids on Medicaid have combined to make the rollout a scattershot effort.

For families with private insurance, there should be no out-of-pocket cost to have your baby immunized against RSV with Beyfortus, as mandated by the Affordable Care Act with rare exceptions.

Nirsevimab purchase cost $495 per dose for 50mg and 100mg doses. $990 per dose for a 200mg dose (Two 100mg doses)

Beyfortus reduced the risk of MA RSV LRTI by approximately 75% relative to placebo.

Beyfortus starts to work soon after your child receives their dose. Because of how the drug works, they likely won’t feel the drug working. If you have other questions about what to expect from Beyfortus preventive treatment, talk with your child’s doctor.

The most common side effects of BEYFORTUS include rash, and pain, swelling or hardness at the site of your child’s injection. These are not all of the possible side effects of BEYFORTUS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

All healthy full-term babies should be protected with one or the other during the RSV season. Either their mom should have gotten vaccinated between 32 and 36 weeks of pregnancy, or if they’re younger than 8 months old at the time of the start of the RSV season, they should get the Beyfortus antibody.

BEYFORTUS must be administered by a healthcare provider.

According to the FDA, the Arexvy vaccine reduces the risk of developing RSV-associated LRTD (lower respiratory tract disease) by 82.6% and the risk of developing severe RSV-associated LRTD by 94.1%. The ABRYSVO vaccine reduces the risk of LRTD by 65.1% and severe LRTD by 88.9%.

Beyfortus should not be mixed with any vaccine in the same syringe or vial. When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.

There is also a new shot for babies called nirsevimab. It is a type of immunization that can reduce the risk of both hospitalizations and health care visits for RSV in infants.

Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in: Newborns and babies under 1 year of age born during or entering their first RSV season.

Infants (0-1 year of age)

Can Beyfortus cause long-term side effects? At this time, Beyfortus is not known to cause long-term side effects. No long-term side effects were reported in clinical trials of the drug. If you’re concerned about the risk of side effects with Beyfortus, talk with your child’s doctor.