FREQUENTLY ASKED QUESTIONS

Amgen By Your Side FAQs

  • What is Amgen By Your Side?

    Amgen By Your Side is a patient support program designed specifically for you, someone prescribed BKEMV™ (eculizumab-aeeb). After you have enrolled, you will be paired with a dedicated support partner, called a Patient Access Liaison (PAL). Your PAL will serve as your partner, providing nonmedical, personalized support to help as you navigate your unique experience, including information on insurance, cost assistance options, upcoming appointments, and other patient support services.

  • Is Amgen By Your Side free of charge?

    There is no cost to enroll, and there are two ways to join:

    • Option 1: Connect with a Patient Access Liaison (PAL) to help you explore enrollment options. Call 1-866-402-5622.
    • Option 2: Sign up through your doctor’s office. They can start the enrollment on AmgenByYourSide.com and submit it on your behalf. Patient consent is required.
  • Will my treatment be covered by my insurance?

    No matter your current financial situation, we are here to help. Whether you have commercial, government, or no insurance, the Amgen By Your Side team is committed to helping you understand your insurance coverage criteria and to providing financial support options.

  • Will I be eligible for financial support?

    The Amgen SupportPlus Co-Pay program may help eligible patients with commercial or private insurance lower their out-of-pocket costs.*

    *Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay for full Terms and Conditions.

  • How do I enroll?

    Once you and your doctor (and/or healthcare team) decide that an Amgen treatment is right for you, the next step is enrolling in Amgen By Your Side. There is no cost to enroll, and there are two ways to join:

    • Option 1: Connect with a Patient Access Liaison (PAL) to help you explore enrollment options. Call 1-866-402-5622.
    • Option 2: Sign up through your doctor’s office. They can start the enrollment on AmgenByYourSide.com and submit it on your behalf. Patient consent is required.

    Once enrollment is complete, your PAL will be your dedicated partner to help you get started and continue on your treatment, as prescribed by your doctor.

  • What is a Patient Access Liaison (PAL)?

    The Amgen By Your Side team is led by a Patient Access Liaison (PAL). The PAL is a dedicated support partner who helps investigate, explain, and educate on the steps in your treatment experience. They are your partner to support and champion you while accomplishing your treatment goals.

    The PAL can educate and assist you with:

    • Learning about insurance coverage criteria and approval process
    • Understanding cost assistance options
    • Understanding infusion appointment-related information
    • Discussing what to expect at the start of treatment
    • Determining how treatment, as prescribed, can fit into your routine
    • Receiving reminders to help you stay on your Amgen medicine, as prescribed
    • Discovering ways to connect with others, if interested
    • Providing information about additional resources or advocacy groups.
  • Where will I receive my treatment?

    The Amgen By Your Side team can help you plan, coordinate, and manage your ongoing infusion schedule. A Patient Access Liaison (PAL) will work to understand your individual needs. We will partner with you to coordinate appointments, find infusion center locations, and prepare for upcoming appointments, from your first infusion to your last. We will be by your side, striving to empower you to be focused, motivated, and committed to maintaining your treatment goals.

For more information, or if you have specific questions, call 1-844-469-4297

*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay for full Terms and Conditions.

Indication

BKEMV™ (eculizumab-aeeb) is indicated for:

  • The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use: BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.

Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS.

Contraindications: BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Other Infections

Use caution when administering BKEMV to patients with any other systemic infection. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after BKEMV Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing BKEMV for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing BKEMV, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis.

In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during BKEMV treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during BKEMV treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during BKEMV treatment.

If TMA complications occur after BKEMV discontinuation, consider reinstitution of BKEMV treatment, plasma therapy, or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt BKEMV infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

Indication

BKEMV™ (eculizumab-aeeb) is indicated for:

  • The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use: BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.

Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS.

Contraindications: BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Other Infections

Use caution when administering BKEMV to patients with any other systemic infection. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after BKEMV Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing BKEMV for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing BKEMV, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis.

In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during BKEMV treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during BKEMV treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during BKEMV treatment.

If TMA complications occur after BKEMV discontinuation, consider reinstitution of BKEMV treatment, plasma therapy, or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt BKEMV infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.