Granogen

Granogen (Filgrastim) is a drug used to stimulate the production of neutrophils, a type of white blood cell, in the body. It is a synthetic form of human granulocyte-colony-stimulating factor (G-CSF), which is normally produced by the body.

Filgrastim is used in various clinical situations where there is a decrease in neutrophil count, such as:

1. Chemotherapy: After chemotherapy, the level of neutrophils in the blood may decrease, increasing the risk of infections. Filgrastim is used to stimulate their production and reduce the time it takes for the immune system to recover.
2. Bone Marrow Transplant: Patients undergoing bone marrow transplants are often given Filgrastim to speed up the recovery of neutrophil levels after the procedure.
3. Radiation therapy: After radiation therapy, there may also be a decrease in neutrophils, and Filgrastim may be used to speed up their recovery.

The drug is usually administered intravenously or subcutaneously. It is important to note that Filgrastim should only be used as directed and under the supervision of a physician, as improper use or dosage can lead to serious side effects.

Indications Granogen

1. Prevention and treatment of neutropenia: The drug is used to prevent and treat neutropenia, a condition in which the level of neutrophils in the blood is low, especially during chemotherapy or radiation therapy in patients with cancer.
2. Accelerating recovery after bone marrow transplant: After bone marrow transplant, the drug can be used to accelerate the recovery of neutrophil levels.
3. Prevention of infections: During treatment with chemotherapy or bone marrow transplantation, Granogen can be used to prevent the development of infections associated with a decrease in neutrophil levels.
4. Stimulation of neutrophil production prior to peripheral blood collection: When peripheral blood is routinely collected for subsequent use in transplantation, administration of Filgrastim may stimulate neutrophil production and increase the number of neutrophils in the collected blood.

Release form

Granogen is usually available as a powder or injection solution.

Pharmacodynamics

1. Stimulation of granulocyte production: Filgrastim acts directly on the bone marrow to stimulate the proliferation and differentiation of granulocytes (eg, neutrophils), resulting in an increase in their numbers in the blood.
2. Acceleration of recovery of neutrophil white blood cell count: In conditions that are accompanied by neutropenia (decreased levels of neutrophils in the blood), such as chemotherapy or bone marrow transplantation, filgrastim promotes rapid recovery of neutrophil levels and reduces the time to the onset of leukopenic complications.
3. Increased functional activity of neutrophils: Filgrastim may also improve the functional characteristics of neutrophils, such as their ability to phagocytose and migrate to sites of infection.
4. Increased survival time of neutrophils: The use of filgrastim can increase the survival time of neutrophils in the blood, which also contributes to an increase in their number and functional activity.

Pharmacokinetics

1. Absorption: Filgrastim is usually administered subcutaneously or intravenously. Following subcutaneous administration, the drug is rapidly and completely absorbed into systemic bleeding.
2. Distribution: Filgrastim has a high affinity for receptors on the surface of neutrophils. It is distributed evenly throughout all tissues of the body, including the bone marrow, where it stimulates neutrophil production.
3. Metabolism: Filgrastim is metabolized in the body, primarily in the liver, but metabolism is minor. Most doses of the drug are excreted unchanged.
4. Elimination: Filgrastim is primarily eliminated from the body via the kidneys. It has a short half-life, meaning that it is quickly eliminated from the body.

Dosing and administration

1. Directions for use:

   • Granogen is usually administered to the patient intravenously or subcutaneously.
   • Intravenous injections may be given by a healthcare professional in a clinic or hospital.
   • Subcutaneous injections can be performed at home according to the instructions of a doctor or health care professional.

2. Dosage:

   • The dosage of Granogen is determined by the doctor depending on the type of disease, severity of symptoms and individual characteristics of the patient.
   • The usual starting dose is 5 mcg/kg of the patient's body weight once daily.
   • Depending on the response to treatment, the dosage may be adjusted by your doctor.

3. Duration of treatment:

   • The duration of treatment with Granogen is also determined by the doctor and depends on the nature of the disease and the patient's response to treatment.
   • Treatment may be short-term (eg, during chemotherapy) or long-term (eg, in chronic forms of neutropenia).

Use Granogen during pregnancy

Use of Granogen during pregnancy requires caution, especially if the mother is receiving chemotherapy for cancer. There are limited data on the effects of filgrastim during pregnancy, and it is often avoided in pregnant women.

One study found that there were no statistically significant differences in mean age at birth, congenital anomalies, or birth weight between infants exposed to filgrastim/pegfilgrastim plus chemotherapy and infants exposed to chemotherapy alone. This study found no increased risk of birth defects or other long-term medical problems in infants exposed to filgrastim in utero (Cardonick et al., 2012).

Due to limited data and potential risks, use of filgrastim during pregnancy should only occur after careful discussion with a physician who can evaluate all potential risks and benefits of its use.

Contraindications

1. Hypersensitivity: People with known hypersensitivity to filgrastim or to any of the ingredients of the drug should not use Granogen.
2. Tumor diseases with an uncertain diagnosis: Granogen may stimulate tumor growth, so its use may be contraindicated in patients with tumor diseases that do not have a definite diagnosis.
3. Major granulocytopenia: The use of Granogen may be contraindicated in patients with multiple myeloma or other types of diseases accompanied by a significant decrease in the level of granulocytes in the blood.
4. Allergic reactions: Some patients may experience allergic reactions to filgrastim, which may be a contraindication to its further use.
5. Pregnancy and breastfeeding: There is limited information on the safety of filgrastim during pregnancy and breastfeeding, so its use during this period should be carried out only on the advice of a doctor.
6. Paediatric population: The safety and efficacy of Granogen in children may not be fully understood, so its use in children may require consultation with a physician.

Side effects Granogen

1. Bone pain: Some patients may experience bone or muscle pain while using Filgrastim.
2. Headache: Headache may occur in some patients as a result of using the drug.
3. Abdominal pain: Some patients may experience pain or discomfort in the abdominal area.
4. Muscle spasms: Filgrastim may cause muscle spasms, or painful muscle contractions.
5. Osteoporosis: Long-term use of Filgrastim may lead to osteoporosis, which increases the risk of fractures.
6. Fluid Retention: Some patients may experience fluid retention in the body, leading to edema.
7. Hyperthermia: Rarely, patients may experience an increase in body temperature.
8. Allergic reactions: In rare cases, allergic reactions such as skin rash, itching, swelling of the face or throat, angioedema may occur.

Overdose

1. Myeloproliferative disorders: Excessive stimulation of the bone marrow with filgrastim may lead to the development of myeloproliferative disorders such as leukemia or myelofibrosis.
2. Leukostasis syndrome: In rare cases, some patients may develop leukostasis syndrome, characterized by extremely high levels of white blood cells in the blood and their activation, which can lead to thromboembolic complications.
3. Pain symptoms and muscle spasms: Some patients may experience pain symptoms after using filgrastim, including muscle spasms and bone pain.
4. Symptoms of an allergic reaction: Allergic reactions such as hives, itching, swelling of the throat or face, difficulty breathing, and anaphylaxis may occur.
5. Acute respiratory complications: In rare cases, acute respiratory complications such as acute respiratory failure, pneumonia, or acute pulmonary distress syndrome may occur.

Interactions with other drugs

1. Medicines that affect bone marrow: Medicines such as chemotherapy or radiation therapy can affect the bone marrow, which may affect how well Granogen works.
2. Drugs that increase neutropenia: Drugs that cause neutropenia (low neutrophil levels) may affect how your body responds to filgrastim.
3. Medicines that affect the immune system: Medicines such as immunosuppressants may affect the immune system and interact with Granogen.
4. Drugs that affect kidney function: Because filgrastim is eliminated from the body via the kidneys, drugs that affect kidney function may alter its metabolism and elimination from the body.
5. Medicines affecting the blood system: Medicines such as anticoagulants may interact with Granogen due to their effects on the blood system.