COVID-19

Hydroxychloroquine/Teva

(hydroxychloroquine sulfate)

Hydroxychloroquine Teva (hydroxychloroquine sulfate) is a generic drug of Plaquenil (hydroxychloroquine sulfate) and is a medicine for treating uncomplicated malaria, chronic discoid lupus erythematosus, systemic lupus erythematosus, and acute and chronic rheumatoid arthritis in adults.

Teva

Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is a multinational pharmaceutical company with dual headquarters in Petah Tikva, Israel and Parsippany, New Jersey, U.S.

Product Overview

Hydroxychloroquine/Teva Indications

Note that Hydroxychloroquine Teva (hydroxychloroquine sulfate) is a generic drug of Plaquenil (hydroxychloroquine sulfate) [1] and is indicated for the treatment of uncomplicated malaria due to plasmodium falciparum, plasmodium malariae, plasmodium ovale, and plasmodium vivax. It is also indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. The precise mechanism by which hydroxychloroquine exhibits activity against plasmodium is not known. Hydroxychloroquine, like chloroquine, is a weak base and may exert its effect by concentrating in the acid vesicles of the parasite and by inhibiting polymerization of heme. It can also inhibit certain enzymes by its interaction with DNA.[2]

COVID-19 (SARS-CoV-2)

Hydroxychloroquine is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. There is no currently available data from Randomized Clinical Trials (RCTs) to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection.

Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally different hydroxychloroquine dosing such as: 400mg BID on day one, then daily for 5 days; 400 mg BID on day one, then 200mg BID for 4 days; 600 mg BID on day one, then 400mg daily on days 2-5.[3]

Trials and Off-Label Use

SOLIDARITY trial (ongoing)

The World Health Organization (WHO) is focusing on what it says are the four most promising therapies for COVID-19: an experimental antiviral compound called remdesivir; the malaria medications chloroquine and hydroxychloroquine; a combination of two HIV drugs, lopinavir and ritonavir; and that same combination plus interferon-beta, an immune system messenger that can help cripple viruses.

This was initiated by the WHO on March 20, 2020. Enrolling subjects in SOLIDARITY is easy. When a person with a confirmed case of COVID-19 is deemed eligible, the physician can enter the patient’s data into a WHO website, including any underlying condition that could change the course of the disease, such as diabetes or HIV infection. The participant has to sign an informed consent form that is scanned and sent to WHO electronically. After the physician states which drugs are available at his or her hospital, the website will randomize the patient to one of the drugs available or to the local standard care for COVID-19. Physicians will record the the duration of the hospital stay or death, and whether the patient required oxygen or ventilation.[4]

Discovery (add-on) trial (ongoing)

On March 22, 2020, the French biomedical research agency INSERM announced they would conduct an add-on study to SOLIDARITY. They will follow WHO’s example and will include 3200 patients from at least seven countries, including 800 from France. This trial will test the same drugs, with the exception of chloroquine.[4]

Off-label use

It is always possible - should your treating doctor decide so - to use a medication for another indication than the approved one. This is called off-label use and is legally allowed. Should you be in need of the medication off-label, for an indication such as COVID-19, ask your treating doctor for consideration. We can legally provide the medication based on an off-label prescription.

Please be aware, should you agree to the off-label use of a medication, that you act on your own responsibility since the medicine has not been approved for the used indication.

Contraindications & Side-effects

Contraindications

Use of hydroxychloroquine sulfate is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Use with caution in patients with gastrointestinal, neurological, or blood disorders, and in those with a sensitivity to quinine.[2]

Side effects

Some serious and common side effects listed in the prescribing information include[2]:

  • bone marrow failure
  • cardiomyopathy
  • vertigo
  • irreversible retinopathy
  • nausea
  • fatigue

What is Cabometyx (cabozantinib) for?

Cabometyx (cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (a type of kidney cancer) who have received prior anti-angiogenic therapy[1,2](therapy that inhibits the formation of new blood vessels that supply the tumour with oxygen and nutrients[5]). In December 2017 the FDA extended the approval to previously untreated patients with advanced renal cell carcinoma (RCC)[6] and in January 2019 the approval was also extended to patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib[9].

How does Cabometyx (cabozantinib) work?

The active substance in Cabometyx, cabozantinib, is a ‘tyrosine kinase inhibitor’.

This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer. By blocking the activity of these enzymes in cancer cells, Cabometyx (cabozantinib) reduces the growth and spread of the cancer[3].

Is Cabometyx (cabozantinib) been approved?

Cabometyx (cabozantinib) was approved for advanced renal cell carcinoma previously treated with an anti-angiogenic therapy by:

  • Food and Drug Administration (FDA), USA:
  • April 25, 2016[4] as second line treatment
  • December 19, 2017[6] as first line treatment
  • January 14, 2019[9] for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
  • European Medical Agency (EMA), European Union, September 9, 2016[3]
  • Therapeutic Goods Administration (TGA), Australia, January 19, 2018[7]
  • Health Canada September 13, 2018[8].

How is Cabometyx (cabozantinib) taken?

The standard dosage is:

  • 60 mg orally, once daily
  • Patients should not eat for at least 2 hours before and at least 1 hour after assumption
  • Cabozantinib tablets should not be substituted with cabozantinib capsules.  

Complete information about Cabometyx (cabozantinib) dosage and administration can be found in the references section.

Note: Consult your treating doctor for personalised dosing.

Common adverse reactions

The most common adverse reactions (≥ 25% of patients) listed in the prescribing information include[1,2,7]:

  • diarrhea
  • fatigue
  • nausea
  • decreased appetite
  • hypertension
  • palmar-plantar erythrodysesthesia (PPE)
  • weight decreased
  • vomiting
  • dysgeusia
  • stomatitis.

Serious side effects

The serious adverse reactions listed in the prescribing information include:

  • hemorrhage
  • gastrointestinal (GI) perforations and fistulas
  • thrombotic events
  • hypertension and hypertensive crisis
  • severe diarrhea
  • palmar-plantar erythrodysesthesia (PPE)
  • reversible posterior leukoencephalopathy syndrome (RPLS).
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Approval Information

This medicine has been approved by the following regulatory bodies:

- European Medicines Agency (EMA)
- Food and Drug Administration (FDA)
- Health Canada
- Therapeutic Goods Administration
- Medsafe (NZ)

Off Label Warning

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Emergency and Off-Label use of COVID Medicines

The World Health Organization has announced that Thailand will join a multi-country clinical study for potential treatments for COVID-19, part of a rapid global search for drugs to treat COVID-19.

In addition to Thailand, the “Solidarity trial” will include the participation of Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain and Switzerland.

“This global problem requires urgent global solutions,” said Daniel Kertesz, WHO Representative to Thailand. “Thailand will be a valued partner in hosting studies to evaluate whether potential treatments are effective – The goal is to identify medicines that will save lives in the global battle to fight this virus.

”The Solidarity trial will test four different drugs or combinations
- remdesivir, a combination of two drugs, lopinavir and ritonavir
- interferon beta
- chloroquine

and will compare their effectiveness to what is called standard of care — the regular support hospitals treating COVID-19 patients use now.Furthermore, the WHO Representative urged Thailand and other countries to not let up on efforts to defeat the coronavirus:  

“We must use every opportunity to reduce the spread of COVID-19 between people. Public health authorities will continue to do their part – by testing for COVID-19, isolating cases quickly to prevent transmission of the virus, treating them and tracing their contacts. But every person has the capacity to contribute, to protect themselves, to protect others, whether at home, in your community, at the workplace or on the transport system.”

WHO Solidarity Trial