Extavia 0.3mg Inj Kit

Interferon beta-1b is a cytokine that possesses antiviral, antiproliferative, and immunomodulatory properties. Its exact mechanism of action in multiple sclerosis (MS) is not fully understood but is thought to involve the modulation of the inflammatory response and reduction of T-cell proliferation, thereby reducing the frequency of exacerbations and slowing the progression of disability in MS.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
New or worsening behavioral or mood changes, such as:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance
Swollen glands
Chest pain
Unexplained bruising or bleeding
Erectile dysfunction
Abnormal vaginal bleeding
Low white blood cell counts, which may increase the risk of infection. If you experience symptoms such as fever, chills, or sore throat, contact your doctor right away.

Heart Problems

This medication may worsen existing heart problems, such as heart failure. If you experience any of the following symptoms, contact your doctor immediately:

Fast heartbeat
Increased need to urinate at night
Shortness of breath
Swollen ankles
Tightness in the chest
Decreased ability to exercise
Inability to lie flat in bed

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Irritation at the injection site
Flu-like symptoms, including:
+ Headache
+ Weakness
+ Fever
+ Chills
+ Aches
+ Pains
+ Sweating (mild pain medications may help)
Stomach pain
Trouble sleeping
Muscle pain
Muscle tension
Frequent urination
* Feeling tired or weak

Reporting Side Effects

If you have questions about side effects or would like to report any, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, discuss this with your doctor, as some products may contain latex.

Regular blood tests will be necessary, as directed by your doctor. Be sure to follow their instructions and discuss any concerns with them. Additionally, consult your doctor before consuming alcohol.

This medication is not a cure for multiple sclerosis (MS); therefore, it is crucial to continue under your doctor's care. Some formulations of this drug may contain albumin, a component of blood, which can potentially harbor viruses that may cause disease. Although the medication is thoroughly screened, tested, and treated to minimize the risk of infection, discuss this with your doctor.

Common reactions at the injection site include redness, pain, itching, and swelling. In some cases, these reactions can be severe and may require hospitalization or surgical intervention. If you experience any reaction that bothers you, is severe, or does not improve within a few days, consult your doctor. Seek immediate medical attention if you notice any break in the skin, color changes (such as blue or black discoloration), or signs of skin infection like oozing, heat, swelling, or pain at the injection site.

Rare but serious health problems, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), have been associated with medications like this one. In some cases, TTP/HUS can be fatal and may occur several weeks to years after starting treatment. If you experience extreme fatigue or weakness, bruising or bleeding, changes in balance or vision, alterations in urine output, dark urine, fever, pale skin, difficulty speaking or thinking, weakness on one side of the body, or yellowing of the skin or eyes, contact your doctor immediately.

Another potentially life-threatening condition, capillary leak syndrome (CLS), has been linked to this medication. If you notice signs of CLS, such as changes in urine output, inability to urinate, blood in the urine, rapid or irregular heartbeat, chest pain or pressure, dizziness or fainting, shortness of breath, significant weight gain, swelling, vomiting blood or coffee ground-like material, or black, tarry, or bloody stools, seek medical attention right away.

High blood pressure in the lungs (pulmonary hypertension) has also been reported in patients taking this medication, which can be severe and may require hospitalization. In one case, a patient required a lung transplant. If you experience new or worsening fatigue, weakness, or shortness of breath, inform your doctor promptly.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Myelosuppressive agents (e.g., azathioprine, methotrexate): May increase risk of myelosuppression.
• Hepatotoxic drugs: May increase risk of liver injury.

• Vaccines (live attenuated): Avoid concurrent administration due to immunosuppressive effects of interferon beta-1b.
• Immunosuppressants: Increased risk of infection or additive immunosuppression.

• Flu-like symptoms (fever, chills, myalgia, fatigue)
• Injection site reactions (redness, swelling, pain, necrosis)
• Symptoms of liver injury (unexplained nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice)
• Symptoms of depression or suicidal ideation
• Symptoms of thyroid dysfunction (fatigue, weight changes, mood changes)
• Symptoms of allergic reactions (rash, itching, difficulty breathing)

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Interferon beta-1b has been associated with an increased risk of low birth weight and spontaneous abortion in some studies, though data are conflicting. A pregnancy registry is available.

Interferon beta-1b is a large protein, and its excretion into breast milk is expected to be minimal. Oral absorption by the infant is also unlikely due to degradation in the infant's gastrointestinal tract. However, caution is advised, and the decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Extavia, and any potential adverse effects on the breastfed infant.

Safety and efficacy have not been established in pediatric patients under 18 years of age. Use in pediatric MS is off-label and generally considered only after careful risk-benefit assessment.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Extavia (Interferon Beta-1b) is a self-injectable medication for relapsing forms of MS, typically given every other day.
• Flu-like symptoms are common, especially at the start of therapy. Pre-medication with NSAIDs or acetaminophen and injecting at bedtime can help manage these.
• Injection site reactions (redness, pain, swelling, and sometimes necrosis) are common. Proper injection technique and site rotation are crucial.
• Regular monitoring of CBC, LFTs, and thyroid function is essential due to potential hematologic, hepatic, and thyroid abnormalities.
• Patients should be monitored for depression and suicidal ideation, as these can be exacerbated by interferon therapy.
• Extavia requires refrigeration but can be stored at room temperature for a limited time before use (check package insert for specifics).

• Other Interferon Beta products (e.g., Interferon Beta-1a [Avonex, Rebif], Peginterferon Beta-1a [Plegridy])
• Glatiramer acetate (Copaxone, Glatopa)
• Oral disease-modifying therapies (e.g., Fingolimod, Siponimod, Ozanimod, Dimethyl fumarate, Teriflunomide, Cladribine)
• Infusion therapies (e.g., Natalizumab, Ocrelizumab, Alemtuzumab)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it occurred.