To date, more than 90 children and young adults have been treated with Zokinvy, resulting in 414 patient-years of treatment exposure.2
The most frequently occurring adverse reactions are: vomiting (86%), diarrhoea (78%), increased aspartate aminotransferase (64%), increased alanine aminotransferase (50%), decreased appetite (41%), nausea (38%), abdominal pain (35%), fatigue (29%), decreased weight (27%), constipation (18%) and upper respiratory tract infection (11%).1
Most adverse reactions occurred within the first 4 weeks following initiation of treatment and in general steadily decreased with increasing duration of treatment. Only 4 patients (6%) discontinued due to adverse reactions.1
The most serious adverse reactions are increased alanine aminotransferase (3.6%), increased aspartate aminotransferase (3.6%), cerebral ischaemia (3.2%), pyrexia (1.6%) and dehydration (1.6%).1
Adverse reactions:1
Frequencies: Very common (≥1/10); Common (≥1/100 to <1/10).
aAbdominal pain includes abdominal pain and abdominal pain upper
| System organ class | Very common | Common |
|---|---|---|
| Infections and infestations | Upper respiratory tract infection | Infection, Rhinitis, Gastroenteritis, Influenza, Oral pustule, Perirectal abscess, Pneumonia, Sinusitis |
| Blood and lymphatic system disorders | Haemoglobin decreased | White blood cell count decreased |
| Metabolism and nutrition disorders | Decreased appetite, Weight decreased | Dehydration, Hypermagnesaemia, Hypokalaemia, Hypoalbuminaemia, Hyponatraemia |
| Psychiatric disorders | Depressed mood | |
| Nervous system disorders | Cerebral ischaemia, Headache, Dizziness, Paraesthesia | |
| Respiratory, thoracic and mediastinal disorders | Cough, Epistaxis, Laryngeal/oropharyngeal pain, Nasal congestion | |
| Gastrointestinal disorders | Vomiting Diarrhoea, Nausea, Abdominal paina, Constipation | Flatulence, Colitis, Dyspepsia, Gastritis, Lower gastrointestinal haemorrhage |
| Hepatobiliary disorders | Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood bicarbonate decreased | Blood creatinine decreased |
| Skin and subcutaneous tissue disorders | Rash, Pruritus, Dry skin, Skin hyperpigmentation | |
| Musculoskeletal and connective tissue disorders | Musculoskeletal pain, Back pain, Pain in extremity | |
| General disorders and administration site conditions | Fatigue | Fever, Chest pain, Chills |
| Injury, poisoning and procedural complications | Tooth fracture |
aAbdominal pain includes abdominal pain and abdominal pain upper
Adverse reactions may be reduced by reverting to the starting dosage of 115 mg/m2 twice daily.1
For patients who are on the maximum maintenance daily dose and are experiencing repeated episodes of vomiting and/or diarrhoea resulting in dehydration or weight loss, their dose can be reduced to the starting dose.1
Prophylactic administration of loperamide to treat diarrhoea is allowed. The dose of loperamide should not exceed 1 mg daily. In the event more than 1 mg of loperamide daily is to be administered, the dose should be slowly increased with caution as needed to treat diarrhoea. Patients experiencing diarrhoea and treated with the anti-diarrhoeal loperamide should be monitored for adverse reactions associated with increased exposure to loperamide.1