Unituxin (Dinutuximab) injection 17.5mg/5ml

Unituxin (Dinutuximab) is a monoclonal antibody used primarily in the treatment of high-risk neuroblastoma, a type of cancer that most commonly affects children. Unituxin is administered as an intravenous infusion and works by targeting specific cancer cells and stimulating the immune system to attack and destroy them. As a part of immunotherapy, it plays a crucial role in increasing survival rates in pediatric oncology.

How It Works

Mechanism of Action

Dinutuximab, the active ingredient in Unituxin, is a chimeric monoclonal antibody that specifically binds to GD2, a glycolipid that is highly expressed on the surface of neuroblastoma cells and some melanomas. Here’s how it works:

1. Targeting GD2:
   • GD2 is a glycolipid present in abundance on the surface of neuroblastoma cells. Dinutuximab binds to this glycolipid with high specificity, marking the cancer cells for destruction.
2. Immune System Activation:
   • Once Dinutuximab attaches to GD2, it activates components of the immune system, such as natural killer (NK) cells and macrophages, through mechanisms like antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). This enhances the body’s ability to recognize and destroy the neuroblastoma cells.
3. Cell Death:
   • The targeted neuroblastoma cells are eventually destroyed via immune responses triggered by Dinutuximab. This action helps to reduce tumor size and prevent the spread of cancer.
4. Synergistic Use with Other Agents:
   • Dinutuximab is often used in combination with GM-CSF (granulocyte-macrophage colony-stimulating factor), IL-2 (interleukin-2), and retinoic acid. These agents help to further stimulate immune activity and improve the efficacy of treatment.

Side Effects

While Unituxin is an effective therapy for neuroblastoma, it is associated with a range of side effects, some of which can be serious.

Common Side Effects

• Pain:
  • Pain is the most common side effect of Dinutuximab. This can occur at the site of the cancer or throughout the body, often requiring the use of opioids to manage.
• Hypotension:
  • Low blood pressure can occur during or after the infusion, which may require medical intervention to stabilize.
• Fever:
  • Fever is frequently reported, particularly during the first few doses of treatment.
• Capillary Leak Syndrome:
  • This condition leads to fluid leaking out of the blood vessels, causing swelling, low blood pressure, and reduced blood flow to vital organs.
• Urticaria (Hives):
  • Skin rashes and hives can occur as a reaction to the antibody.
• Nausea and Vomiting:
  • Gastrointestinal symptoms like nausea and vomiting are common, especially during the infusion period.

Serious Side Effects

• Infusion Reactions:
  • Severe allergic reactions, including anaphylaxis, can occur during the infusion. Symptoms may include difficulty breathing, wheezing, swelling of the face, and a rapid heart rate. This requires immediate medical intervention.
• Neuropathy:
  • Unituxin can cause nerve pain (neuropathy), especially in the arms and legs. It may also affect sensation and motor control.
• Hypersensitivity Reactions:
  • Severe allergic reactions, characterized by itching, swelling, and rash, may occur. Close monitoring is essential during infusion.
• Increased Risk of Infection:
  • Due to immune modulation, patients may be at an increased risk for bacterial, viral, or fungal infections.

Indications

Unituxin is specifically indicated for:

• High-Risk Neuroblastoma:
  • Unituxin is used in pediatric patients with high-risk neuroblastoma. It is typically administered after achieving at least a partial response to prior first-line therapies, such as chemotherapy, surgery, or radiation therapy, and is often used in combination with GM-CSF, IL-2, and isotretinoin (retinoic acid).

Contraindications

Unituxin should not be used in certain populations or under specific conditions due to potential health risks.

• Hypersensitivity to Dinutuximab:
  • Unituxin is contraindicated in patients with known hypersensitivity to Dinutuximab or any excipients in the formulation.
• Severe Neuropathies:
  • Patients with pre-existing or severe peripheral neuropathies should not receive Dinutuximab, as the drug may worsen nerve damage and pain.
• Severe Infusion Reactions:
  • If a patient has experienced severe or life-threatening infusion reactions, Unituxin should be discontinued and not restarted.
• Pregnancy and Lactation:
  • Unituxin is not recommended for use during pregnancy due to the potential for harm to the fetus. It is also contraindicated during breastfeeding, as it is unknown whether Dinutuximab is excreted in human milk.

Pricing Information

The cost of Unituxin can vary depending on the country, availability, and healthcare system. Below is a table summarizing approximate prices in different countries:

Country	Price (per 17.5mg/5ml vial)	Reference
United States	$20,000 – $25,000	GoodRx
United Kingdom	£18,000 – £23,000	NHS BNF
Germany	€21,000 – €26,000	MedizinFuchs
Canada	CAD $28,000 – $30,000	Canada Drugs
Australia	AUD $32,000 – $35,000	PBS

Top 5 Global Brands

In the field of oncology and pediatric cancer treatments, several global pharmaceutical companies are leading the way in producing advanced therapies like Unituxin. Below are the top 5 global brands involved in cancer immunotherapy and treatment:

1. United Therapeutics Corporation:
   • The developer of Unituxin, United Therapeutics is a leader in rare disease therapies and pediatric oncology treatments.
2. Novartis:
   • Known for its robust oncology portfolio, Novartis plays a key role in the development and distribution of cutting-edge cancer treatments.
3. Roche:
   • Roche is a pioneer in the field of cancer immunotherapy and personalized medicine, with an extensive range of treatments for various cancers.
4. Pfizer:
   • As one of the largest global pharmaceutical companies, Pfizer is actively involved in oncology research and the development of monoclonal antibody therapies.
5. Bristol-Myers Squibb:
   • Bristol-Myers Squibb is known for its innovations in cancer immunotherapy, particularly in developing therapies for solid tumors and rare cancers.