Hydroxychloroquine/Teva (hydroxychloroquine sulfate)

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

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

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

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. TheSocialMedwork 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

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 include²:

• bone marrow failure

• cardiomyopathy

• vertigo

• irreversible retinopathy

• nausea

• fatigue

Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Hydroxychloroquine Teva (hydroxychloroquine sulfate) for the approved indication^1,2,5,6,7,8.

References

1. Full prescribing information [FDA]: Plaquenil (hydroxychloroquine sulfate) [PDF], Concordia, June 2018.

2. Full prescribing information [FDA]: Hydroxychloroquine Teva (hydroxychloroquine sulfate) [PDF], Teva, Nov 2017.

3. Information for Clinicians on Therapeutic Options for COVID-19 Patients. Accessed March 2020.

4. WHO launches global megatrial of the four most promising coronavirus treatments. Accessed March 2020.

5. Public assessment report [CBG, NL]: Hydroxychloroquine sulfate [PDF], College Ter Beoordeling van Geneesmiddelen, Jan 2019.

6. Product information [TGA]: Plaquenil (hydroxychloroquine sulfate) [PDF], Sanofi-Aventis, December 2019.

7. Product monograph [Health Canada]: Plaquenil (hydroxychloroquine sulfate) [PDF], Sanofi-Aventis, August 2019.

8. Product detail [Medsafe]: Plaquenil (hydroxychloroquine sulfate) [PDF], Sanofi-Aventis, December 2018.