Diabetes medications, antifungals, JAK inhibitors and more were included in this month's latest release.
The Therapeutic Goods Association released a long list of updates on February 17.
The JAK inhibitor tofacitinib (Xeljanz) had a new warning added, as at least one case of progressive multifocal leukoencephalopathy (PML) has been confirmed in RA patients receiving it post-marketing.
As PML can be fatal, it should be considered in the differential diagnosis of immunosuppressed patients with new or worsening neurological symptoms.
Upadacitinib (Rinvoq), another JAK inhibitor, now advises that semen discolouration is a potential adverse effect from the post marketing experience. Most reports occurred with a 45mg dose, and the blue or green colour lessened or resolved following reduction or discontinuation of medication.
The antifungal medication posaconazole (Noxafil) is now contraindicated with rivaroxaban or apixaban, as it may increase the plasma concentration of these medicines and increase the risk of bleeding.
Itraconazole (Itracap), another antifungal, had its contraindicated medication list expanded. It also had a huge number of adverse effects added, such as oedema, leukopenia, anaphylactic reaction, hypertriglyceridaemia, tremor, visual disturbance, transient or permanent hearing loss, tinnitus, congestive heart failure, pancreatitis, hyperbilirubinaemia, alopecia and many more.
Rituximab (Riximyo), a monoclonal antibody, is now contraindicated in active, severe infections, immunocompromised patients, severe heart failure and severe, uncontrolled cardiac disease.
Acarbose (Glybosay), used to improve blood sugar control, has four new contraindications: severe hepatic impairment, colonic ulceration, chronic intestinal disease and diabetic ketoacidosis.
Additionally, warnings are now included about coadministration of antacids, fulminant hepatitis, renal impairment and drug interactions with colestyramine. Acute generalised exanthematous pustulosis has been included as a potential adverse effect.
Another blood sugar medication, empagliflozin/metformin hydrochloride (Jardiamet), was updated to include a warning for patients with known or suspected mitochondrial diseases.
The anticoagulant medication bivalirudin (Apotex) had five new contraindications added: acute gastric or duodenal ulcer, cerebral haemorrhage, severe cerebro-spinal trauma, diabetic or haemorrhagic retinopathy and proximal use of spinal/epidural anaesthesia.
Estradiol hemihydrate (Zumenon) was updated to include 10 new adverse effects: haemolytic anaemia, leg cramps, back pain, pelvic pain, change in cervical secretion and menorrhagia, asthenia, headache, abdominal pain/nausea, breast pain and dysmenorrhoea.
The vascular disorders section of adverse effects was updated to include hypertension, peripheral vascular disease, varicose vein and venous thromboembolism, and the frequency of oedema/peripheral oedema was updated.
Added to special warning and precautions for use were coronary artery disease, combined estrogen-progestogen therapy, estrogen-only, ischaemic stroke and no safety data to support oral doses of estradiol greater than 2mg.
Information on pregnancy during treatment, metabolism of progesterone and the effect on uterine bleeding profile is now included.
Additional adverse effects for testosterone enantate (Primoteston Depot) include increased appetite, hypercholesterolaemia, blood triglycerides increased, increased blood cholesterol, emotional disorder, migraine, tremor, bronchitis, sinusitis, snoring, decreased urine flow, urinary retention, urinary tract disorder, nocturia, dysuria, dry skin, muscle disorder, musculoskeletal stiffness, abnormal prostate and many more.
A new interaction was also added, with a warning to co-administer with ACTH or corticosteroids cautiously as they could promote oedema formation, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema.
Access the full list of updates here.
