Understanding Pyzchiva (ustekinumab-ttwe)
Pyzchiva, with the generic name ustekinumab-ttwe, is a prescription medication approved by the U.S. Food and Drug Administration (FDA) [1.4.3]. It is classified as a biosimilar to the reference drug, Stelara (ustekinumab) [1.3.5]. This means it is highly similar to, and has no clinically meaningful differences from, Stelara in terms of safety, purity, and potency [1.5.2]. Pyzchiva is manufactured by Samsung Bioepis and will be commercialized in the United States by Sandoz, expected to be available in February 2025 [1.4.4, 1.4.5].
How Does Pyzchiva Work?
The mechanism of action for Pyzchiva involves its active substance, ustekinumab, which is a human monoclonal antibody [1.5.4]. It works by targeting and binding to the p40 protein subunit shared by two specific cytokines: interleukin-12 (IL-12) and interleukin-23 (IL-23) [1.5.3, 1.5.6]. These cytokines are naturally occurring proteins involved in immune and inflammatory responses [1.5.2]. In autoimmune diseases, the regulation of IL-12 and IL-23 is abnormal, leading to chronic inflammation. By blocking these cytokines, Pyzchiva disrupts the inflammatory pathways (specifically the Th1 and Th17 pathways) that are central to the pathology of conditions like psoriasis and inflammatory bowel disease, thereby reducing inflammation and symptoms [1.5.6].
What is Pyzchiva Used For? Approved Indications
Pyzchiva is FDA-approved to treat the same conditions as its reference medicine, Stelara. The primary uses are for several inflammatory autoimmune diseases [1.2.2, 1.2.7]:
- Moderate to Severe Plaque Psoriasis (PsO): For adults and children aged 6 years and older who are candidates for systemic therapy or phototherapy [1.2.2].
- Active Psoriatic Arthritis (PsA): For adults and children aged 6 years and older. It can be used alone or in combination with other medications [1.2.2].
- Moderately to Severely Active Crohn's Disease (CD): For adult patients who have failed or were intolerant to other therapies [1.2.2].
- Moderately to Severely Active Ulcerative Colitis (UC): For adult patients [1.2.2].
Administration and Dosage
Pyzchiva administration depends on the condition being treated. For Crohn's disease and ulcerative colitis, treatment begins with a single weight-based intravenous (IV) infusion performed by a healthcare professional [1.7.5]. After the initial IV dose, treatment continues with subcutaneous (under the skin) injections, typically 90 mg every 8 weeks [1.7.3].
For plaque psoriasis and psoriatic arthritis, the dosage is administered as a subcutaneous injection. The specific dose (45 mg or 90 mg) and frequency (typically every 12 weeks after initial starter doses) depend on the patient's weight and condition [1.7.1]. For some patients, a healthcare provider may determine it is appropriate for the patient or a caregiver to administer the subcutaneous injections at home after proper training [1.7.5].
Potential Side Effects and Safety Information
As with all medications that affect the immune system, Pyzchiva has potential side effects. It is crucial to discuss these with a healthcare provider.
Common Side Effects
The most common adverse reactions can vary slightly by condition but often include [1.6.4, 1.6.5]:
- Nasal congestion, sore throat, and runny nose (nasopharyngitis)
- Upper respiratory infections
- Headache
- Fatigue
- Nausea and vomiting
- Diarrhea and stomach pain
- Itching
- Redness at the injection site
Serious Warnings and Precautions
Pyzchiva carries warnings for more serious side effects because it lowers the ability of the immune system to fight infections [1.2.1].
- Serious Infections: The medication may increase the risk of serious bacterial, fungal, or viral infections, including tuberculosis (TB). Patients should be evaluated for TB before starting treatment [1.6.6].
- Cancers: As an immunosuppressant, Pyzchiva may increase the risk of certain types of cancer. There have been reports of skin cancer in patients with pre-existing risk factors [1.3.2].
- Posterior Reversible Encephalopathy Syndrome (PRES): A rare but serious brain condition that has been reported. Symptoms include headache, seizures, confusion, and vision problems [1.2.1].
- Hypersensitivity Reactions: Serious allergic reactions (anaphylaxis) can occur. Medical help should be sought immediately for symptoms like swelling of the face, chest tightness, or rash [1.2.1].
- Lung Inflammation: Cases of noninfectious pneumonia have been reported, which may require hospitalization [1.2.1].
| Feature | Pyzchiva (ustekinumab-ttwe) | Stelara (ustekinumab) |
|---|---|---|
| Classification | Biosimilar, Interleukin Inhibitor [1.5.2] | Biologic, Interleukin Inhibitor [1.5.5] |
| Active Ingredient | ustekinumab-ttwe [1.5.2] | ustekinumab [1.3.5] |
| Mechanism | Blocks IL-12 and IL-23 cytokines [1.5.2] | Blocks IL-12 and IL-23 cytokines [1.5.5] |
| Approved Uses | Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis [1.2.2] | Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis [1.3.5] |
| FDA Approval Status | Approved as a biosimilar [1.4.1] | Original FDA-approved biologic [1.5.5] |
Conclusion
In summary, Pyzchiva is a significant addition to the treatment landscape for several chronic inflammatory diseases. As a biosimilar to Stelara, it offers a comparable and effective therapeutic option for patients with moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis [1.3.5]. Its mechanism of targeting IL-12 and IL-23 provides targeted relief from inflammation, but it requires careful monitoring by a healthcare provider due to its effects on the immune system and the potential for serious side effects [1.2.1].
For more information on drug approvals and safety, you can visit the FDA's drug information database. [1.2.2]
