Hodpro — Procarbazine 50 mg

Hodpro is manufactured in the form of capsules for oral use, each containing a strictly calibrated dose of components:

• Active Compound: Procarbazine hydrochloride — equivalent to 50 mg of free base procarbazine per capsule.
• Excipients: Mannitol, maize starch, purified talc, magnesium stearate; hard gelatin capsule components: gelatin, titanium dioxide, colorants.
• Appearance: Hard gelatin capsules. Supplied in cardboard boxes containing either 50 capsules (5 blisters of 10 pieces) or 100 capsules (10 blisters of 10 pieces).

Pharmacodynamics: Procarbazine is an antineoplastic alkylating agent of the hydrazine line. The exact mechanism of action involves the inhibition of protein, DNA, and RNA synthesis. During metabolism, procarbazine generates free radicals (including methyl radicals) that cause guanine methylation, DNA strand breaks, and suppress the normal division of tumor cells.

Pharmacokinetics: Following oral intake, procarbazine is rapidly and almost completely absorbed from the GIT. It readily crosses the blood-brain barrier into the cerebrospinal fluid. It is metabolized primarily in the liver and kidneys to form active cytotoxic metabolites. The elimination half-life of the parent drug is about 10 minutes; it is excreted mainly by the kidneys in urine (up to 70% as metabolites).

Hodpro 50 mg is used strictly as prescribed by a specialized professional (oncologist or hematologist) for the treatment of the following conditions:

• 🔹 Hodgkin's Lymphoma: A malignancy of lymphoid tissue (lymphogranulomatosis) at various stages as part of combination polychemotherapy regimens.
• 🔹 Non-Hodgkin's Lymphomas: Various histological types of lymphosarcomas (within second-line therapy or upon resistance to standard treatment).
• 🔹 Brain Tumors: Malignant gliomas, glioblastoma multiforme, and other neuroepithelial tumors (in combination with lomustine and vincristine — PCV regimen).

Dose calculation and monitoring of therapy are carried out exclusively by medical personnel based on body surface area, diagnosis, and blood counts:

• Recommended Dosage: The standard initial dose is 2–4 mg/kg of body weight daily (approximately 50–200 mg), divided into several administrations. In combination regimens, the dosage and cyclical schedule are determined by the specific protocol (e.g., administration on days 1 to 14 of the cycle).
• Method of Administration: Capsules are taken orally, preferably with or after meals (to reduce dyspeptic symptoms), swallowed whole with a glass of water. Capsules must not be opened, broken, or chewed.
• Dosing Regimen: The medication is taken daily at a strictly fixed time. Upon development of marked hematological toxicity (leukopenia, thrombocytopenia), the dose is temporarily reduced or suspended.
• Duration of Treatment: The duration of therapy is determined individually by the treatment protocol and the number of scheduled chemotherapy cycles, provided efficacy is monitored.

The use of Hodpro capsules is strictly prohibited in the presence of the following contraindications or pathological conditions:

• ⛔ Hypersensitivity: Individual intolerance to procarbazine or any excipient component of the capsule.
• ⛔ Severe Bone Marrow Suppression: Severe leukopenia (less than 3×10⁹/L), thrombocytopenia (less than 100×10⁹/L), or anemia prior to therapy initiation.
• ⛔ Pregnancy and Lactation: Procarbazine possesses potent teratogenic, mutagenic, and embryotoxic effects. Breastfeeding must be completely discontinued during the treatment period.
• ⛔ Severe Organ Insufficiency: Marked decompensated impairment of liver or kidney function. The drug is used with extreme caution in elderly patients.

Procarbazine is a weak monoamine oxidase (MAO) inhibitor, leading to a wide range of clinically significant and hazardous interactions:

• ❌ Tyramine-Rich Foods: It is strictly forbidden to consume aged cheeses, smoked meats, pickled fish, beans, beer, and red wine to avoid developing a severe hypertensive crisis ("cheese syndrome").
• ❌ Alcohol: Concomitant use causes a disulfiram-like reaction (headache, facial flushing, blood pressure drop, tachycardia, nausea). Alcohol consumption is strictly prohibited.
• ❌ Antidepressants: Co-administration with tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) can trigger a life-threatening serotonin syndrome.

The drug is categorized as extremely hazardous to the reproductive system and the developing fetus:

• Risks to the Fetus: Procarbazine causes irreversible chromosomal abnormalities, internal organ malformations, and fetal death. Conception during therapy is absolutely unacceptable.
• Contraception for Women and Men: Patients of both sexes of childbearing potential must utilize reliable (double barrier) methods of contraception during treatment and for at least 3–6 months following its completion.
• Fertility Impact: The drug frequently causes irreversible infertility (azoospermia in men and amenorrhea in women). Men are advised to consider sperm cryopreservation before starting treatment.

Therapy with Hodpro is associated with the development of several adverse reactions that require regular monitoring of laboratory parameters:

• 🟢 Hematotoxicity (Very Common): Leukopenia, thrombocytopenia, anemia; increased risk of developing severe infectious diseases and spontaneous bleeding.
• 🟡 Gastrointestinal Tract: Marked nausea and vomiting (especially in the first days of intake, the severity of which gradually decreases), anorexia, dry mouth, stomatitis, diarrhea, or constipation.
• 🟡 Nervous System: Increased fatigue, drowsiness, dizziness, paresthesia (numbness of extremities), neuropathy, depression, ataxia.
• 🟠 Dermatological Reactions: Skin rash, pruritus, dermatitis, transient alopecia (hair loss).
• ⚠️ Urgent Medical Attention: Upon sudden temperature spike, appearance of signs of infection, chills, unusual bruising or bleeding, or dyspnea, an oncologist must be contacted immediately.

Ingestion of doses significantly exceeding recommended therapeutic ones results in critical damage to the hematopoietic and nervous systems:

• Main Manifestations: Acute overdose presents with uncontrollable vomiting, diarrhea, severe lethargy, tremors, convulsions, hypotension, and subsequent deep bone marrow suppression (pancytopenia).
• First Aid: Immediate discontinuation of the drug, induction of vomiting (if the patient is conscious), ingestion of enterosorbents, and emergency hospitalization in an intensive care unit.
• Treatment: There is no specific antidote. Symptomatic and supportive therapy, including transfusion of blood components, administration of antibiotics, and intensive fluid support, is carried out.

Adherence to the storage rules of the capsules ensures the stability of the molecular structure of procarbazine and patient safety:

• 🌡️ Temperature Regimen: Store in the original packaging in a dry, light-protected place at a controlled room temperature strictly between 15°C and 25°C.
• 📦 Environmental Protection: Protect from high humidity and direct sunlight. Blisters should be removed from the cardboard box only immediately before administration.
• 👶 Accessibility: The medication is a highly toxic cytostatic agent. Store in a secure location, completely excluding access by children, unauthorized individuals, and pets.
• ⏳ Special Instructions: Do not use the drug after the expiration date (24 months) indicated by Neon on the package. Dispose of unused capsules as hazardous medical waste.