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Hyrimoz
Adalimumab
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Hyrimoz
Adalimumab
Select product strength & quantity:

Prescription Required.

Product of Canada.

Shipped from Canada.

Prescription Required.Product of Canada.Shipped from Canada.

What is Hyrimoz?

Hyrimoz is an FDA-approved medication used to treat various inflammatory conditions. It is specifically designed to reduce the signs and symptoms of several autoimmune diseases by inhibiting the action of TNF, a substance in the body that causes inflammation. The drug is administered subcutaneously and is available in two forms: a Sensoready® pen autoinjector and a prefilled syringe.

Chemical Composition and Formulation

The active ingredient in Hyrimoz is adalimumab-adaz, a monoclonal antibody that binds to TNF-alpha, inhibiting its interaction with the TNF receptor. This mechanism helps in reducing inflammatory responses. The formulation is designed for subcutaneous administration and is intended to be used at regular intervals as prescribed by a healthcare provider.

Manufacturer Information

Hyrimoz is manufactured by Sandoz Inc., a global leader in generic pharmaceuticals and biosimilars. Sandoz is known for its commitment to increasing access to high-quality, affordable biologics.

Medical Uses

Primary Indications for Hyrimoz

Hyrimoz is primarily indicated for the treatment of several chronic inflammatory conditions, including:

  • Moderate to severe rheumatoid arthritis in adults
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Moderate to severe Crohn’s disease in adults and children 6 years of age and older
  • Moderate to severe ulcerative colitis in adults
  • Moderate to severe chronic plaque psoriasis in adults
  • Moderate to severe hidradenitis suppurativa in adults
  • Non-infectious intermediate, posterior, and panuveitis

Diseases and Conditions it is Prescribed for

In addition to the primary indications, Hyrimoz is also used in children 2 years of age and older for juvenile idiopathic arthritis. It can be used alone or in combination with other medicines like methotrexate, depending on the specific condition being treated.

Off-label Uses (if any)

Currently, there are no widely recognized off-label uses for Hyrimoz. However, as with any medication, it may be prescribed for conditions not listed in the official indications based on the discretion of the healthcare provider.

This expanded content provides a detailed overview of Hyrimoz, including its composition, manufacturer, and medical uses, based on the information gathered from the provided sources.

Mechanism of Action

How Hyrimoz Works in the Body

Hyrimoz, containing the active ingredient adalimumab, is classified as a biological response modifier and a TNF (tumor necrosis factor) blocker. It is specifically designed to target and neutralize TNF-alpha, an inflammatory protein produced in excess in various autoimmune conditions. By blocking TNF-alpha, Hyrimoz effectively reduces inflammation, pain, and cellular damage in affected areas. The time it takes to notice an improvement in symptoms can range from 4 to 12 weeks, depending on the condition being treated.

Its Effect on the Immune System

As a TNF blocker, Hyrimoz plays a significant role in modulating the immune system. TNF-alpha is a key cytokine in the inflammatory process, and its overproduction can lead to the symptoms associated with autoimmune diseases. By inhibiting TNF-alpha, Hyrimoz helps to dampen the overactive immune response, thereby reducing inflammation and its associated symptoms.

Comparison with Similar Drugs

Hyrimoz is a biosimilar to Humira®, another adalimumab product. Biosimilars are highly similar to their reference products in terms of safety, purity, and potency. While Hyrimoz and Humira® share the same mechanism of action, Hyrimoz may be available at a lower cost, offering an alternative for patients seeking treatment with TNF blockers.

Dosage and Administration

Standard Dosing Information

The dosage of Hyrimoz varies depending on the condition being treated. For adults with conditions like rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the recommended dose is typically 40 mg administered every other week.

Different Dosages for Specific Conditions

  • For Crohn’s disease or ulcerative colitis in adults: An initial dose of 160 mg, followed by 80 mg two weeks later, and then 40 mg every second week starting from the fourth week.
  • For psoriasis or uveitis in adults: An initial dose of 80 mg, followed by 40 mg every other week starting one week after the first dose.
  • For children over 2 years old with uveitis: The dose is based on body weight, with 20 mg every other week for children under 30 kg and 40 mg for those weighing more or equal to 30 kg.

Administration Methods and Guidelines

Hyrimoz is administered via subcutaneous injection, typically in the front of the thigh or abdomen. The medication comes in prefilled syringes or a SensoReady® Pen for ease of use. Patients are usually instructed by a healthcare professional on how to prepare and inject the first dose. It’s crucial to follow the prescribed dosing schedule and not to miss doses for optimal effectiveness.

Side Effects

Common Side Effects

The most common side effects of Hyrimoz include:

  • Headaches
  • Injection site reactions (redness, itching, pain, or swelling)
  • Nausea
  • Skin rash
  • Tiredness
  • Upper respiratory infections (like colds or sinus infections)
  • Weakness

Rare but Serious Side Effects

Some rare but serious side effects include:

  • Abdominal pain
  • Breathing difficulty
  • Chest pain
  • Signs of serious infections (fever, chills, severe diarrhea)
  • Signs of liver problems (yellowing of the skin or eyes, dark urine)
  • Symptoms of pneumonia (fever, shortness of breath, fatigue)

Long-term Side Effects

Long-term use of Hyrimoz may increase the risk of certain conditions such as lymphoma or other cancers, particularly in children and adolescents. It’s important to discuss the potential risks and benefits of long-term treatment with Hyrimoz with a healthcare provider.

This expanded content provides a comprehensive overview of Hyrimoz’s mechanism of action, dosage and administration, and side effects, based on the information from the provided sources.

Warnings and Precautions

Contraindications

Hyrimoz should not be used in individuals who:

  • Are allergic to adalimumab, latex, or any ingredients in the medication.
  • Have severe infections such as sepsis, tuberculosis, or opportunistic infections.
  • Suffer from moderate-to-severe heart failure.

Necessary Precautions for Certain Patient Populations

  • Pregnant Women: The effects of Hyrimoz on pregnant women are unknown. It’s crucial to inform the doctor if you are pregnant or plan to become pregnant before using Hyrimoz.
  • Elderly: Older adults may be more susceptible to side effects and should be monitored closely.
  • Breastfeeding: Hyrimoz passes into breast milk in small amounts. Consult your doctor before breastfeeding.

Interactions with Other Drugs

Hyrimoz may interact with several medications, including:

  • Abatacept
  • Anakinra
  • Warfarin
  • Cyclosporine
  • Theophylline
  • Live vaccines

Patients should inform their healthcare providers about all medications and supplements they are taking.

Clinical Trials and Efficacy

Summary of Key Clinical Trials

Hyrimoz has undergone various clinical trials to establish its efficacy and safety. These trials have primarily focused on its use in treating conditions like rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Efficacy Data and Success Rates

The trials demonstrated that Hyrimoz effectively reduces symptoms and inhibits the progression of these diseases. It has shown significant efficacy in improving physical function and reducing the signs and symptoms in patients with moderately to severely active conditions.

Comparison with Other Treatments

As a biosimilar to Humira (adalimumab), Hyrimoz has shown comparable efficacy and safety profiles. The clinical trials have reinforced its role as an alternative treatment option, offering similar therapeutic benefits to the reference product.

Patient Information

Guidelines for Patients

Patients prescribed Hyrimoz should:

  • Follow the prescribed dosage and administration schedule.
  • Be aware of the potential side effects and when to seek medical attention.
  • Inform their healthcare provider of any other medications they are taking, including over-the-counter drugs and supplements.

What Patients Should Know Before Starting Hyrimoz

Before starting treatment, patients should be aware of:

  • The potential risks and benefits of Hyrimoz.
  • The importance of adhering to the treatment regimen.
  • The need to report any signs of infection or unusual symptoms to their healthcare provider promptly.

Instructions on What to Do in Case of Missed Doses or Overdosing

  • If a dose is missed, administer it as soon as possible and then continue with the regular schedule. Do not double the dose to make up for the missed one.
  • In case of overdosing, seek immediate medical attention or contact a healthcare provider for guidance.

Frequently Asked Questions

Hyrimoz (adalimumab-adaz) is a TNF-blocker biosimilar to Humira, used for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Common side effects include infections, injection site reactions, headache, rash, nausea, abdominal pain, and hypertension.

Hyrimoz is given by subcutaneous injection, typically in the thigh or abdomen. The dosage depends on the condition being treated.

The effects of Hyrimoz on pregnancy are unknown. Consult your doctor if you are pregnant or planning to become pregnant.

Hyrimoz passes into breast milk in small amounts. Consult your doctor before breastfeeding.

If you miss a dose, administer it as soon as possible and then resume your regular schedule. Do not double the dose.

Hyrimoz may interact with drugs like abatacept, anakinra, warfarin, cyclosporine, theophylline, and live vaccines. Inform your doctor about all medications and supplements you use.

Serious side effects include difficulty breathing, swelling of the face, fever, night sweats, skin rash, unusual bleeding, yellowing of the skin or eyes, and severe infections.

Store Hyrimoz in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. It can be stored at room temperature for a limited time if necessary.

Hyrimoz is indicated for children with juvenile idiopathic arthritis aged 2 years and older. The dosage is based on weight.

Before starting Hyrimoz, patients should be evaluated for active tuberculosis and tested for latent infection.

Hyrimoz is effective in reducing symptoms, inducing major clinical response, inhibiting structural damage progression, and improving physical function in adults with moderately to severely active rheumatoid arthritis.

Hyrimoz can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs) for treating rheumatoid arthritis.

If you experience severe side effects like vision loss, heart symptoms, severe headache, or signs of a severe infection, seek medical help immediately or call 911.

Lymphoma and other malignancies have been reported in patients, especially children and adolescents, treated with TNF-blockers like Hyrimoz. Discuss the risks with your doctor.

Yes, Hyrimoz is indicated for reducing symptoms, inhibiting structural damage progression, and improving physical function in adults with active psoriatic arthritis.

For adult Crohn’s disease, the recommended dosage is 160 mg initially, followed by 80 mg two weeks later, and then 40 mg every other week.

Hyrimoz can be stored at room temperature up to a maximum of 77°F (25°C) for up to 14 or 21 days, depending on the product configuration.

Hyrimoz is not a cure but helps manage symptoms and slows disease progression in conditions like rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease.