Thalassemia Patients and Friends

Discussion Forums => Iron Chelation Corner => Topic started by: Sharmin on January 27, 2016, 06:22:17 PM

Title: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on January 27, 2016, 06:22:17 PM

We are working hard to have Jadenu approved in Canada.  I have received word that it will be approved in February 2016 - this will make it easier for patients across Canada to access it.

I will confirm this news with you all soon.

Sharmin

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Canadian_Family on January 28, 2016, 06:49:22 PM

Thanks for the update Sharrmin.

I hope Jadenu will improve chelation compliance further.

Regards

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Parin on January 29, 2016, 08:17:39 AM

Any news when it will be available in INDIA

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on January 29, 2016, 06:16:22 PM

Parin,

I'm not sure who you would consult for that.  We have struggled for a while to have it approved in Canada, and even now we are still waiting.  The drug was created and tested in the US so obviously it is approved there.  It takes time for medications to be approved in other countries.  Mostly, it depends on your own country approving it.  Perhaps, like exjade it will be sold in India under another name. 

I hope we all have access soon,

Sharmin

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Andy Battaglia on January 30, 2016, 05:59:37 PM

Does anyone know if any of the Indian companies, Like Cipla are working on their own version of Jadenu?

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on April 07, 2016, 12:56:55 PM

According to this Jadenu is approved in Canada.  Or at least Health Canada has found it to be compliant..

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/jadenu-dhcpl_lapds-179088-eng.php

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on April 07, 2016, 03:43:55 PM

I spoke with Novartis Canada this morning. As of April 1, 2016 - if prescribed by a Canadian physician Jadenu is now available in Canadian drugstores.  

See below for dosage:

Quote

EXJADE® therapeutic dose range:

10 mg/kg
20 mg/kg
30 mg/kg
40 mg/kg (max. recommended dose)

JADENU™ therapeutic dose range:

7 mg/kg
14 mg/kg
21 mg/kg
28 mg/kg (maximum recommended dose)

Calculated dose example for 50 kg patient receiving EXJADE® 30 mg/kg:

30 mg/kg × 50 kg = 1500 mg/day
Three (3) 500 mg tablets

Calculated dose example for 50 kg patient receiving JADENU™ 21 mg/kg:

21 mg/kg × 50 kg = 1050 mg/day
Three (3) 360 mg tablets

[/center]

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Canadian_Family on April 07, 2016, 07:44:57 PM

Thanks for the update.

This is another option that thal patients can choose.

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Parin on April 08, 2016, 01:52:05 PM

Good News....Looking forward to release in INDIA too.

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on April 11, 2016, 05:21:23 PM

Hello Parin,

I hope it is released in India soon too.  If you have your physician request it, and if you connect with Novartis India you will speed up the release of it, helping yourself and countless others.  See if any of the information below is helpful to you.  

Jadenu is superior to exjade in many ways - while have the same efficacy, it has far fewer toxic side effects.  It is less likely to affect the kidneys, bones, eyes/ears etc. because a lower dose of the medication is required to yield the same amount of chelation.  It is also far better for the stomach.  

Best of luck.  

Quote

Novartis India Limited
Sandoz House, 8th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
India
Phone: +91 22 2495 8400
Fax: +91 22 2497 3938

Alcon Group Pharmaceuticals
Novartis Healthcare Pvt. Ltd.
Salarpuria-Sattva Knowledge City
Raidurg, Rangareddy District
Madhapur / Hyderabad, Rangareddy 500 081
India
Phone: +91 40 6758 1000
Fax: +91 40 6758 1001

Novartis India Limited
Sandoz House, 7th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
India
Phone: +91 22 2495 8400
Fax: +91 22 2497 0361

Novartis Healthcare Private Limited
Sandoz House
Dr. Annie Besant Road
Worli, Mumbai 400 018
India
Phone: +91 22 2495 8888
Fax: +91 22 2497 036

Alcon Group Pharmaceuticals Sandoz
Sandoz Private Limited, Kanjurmarg Site
iThink Techno Campus
Phase 1, Alpha Building, Ground Floor
Off. Jogeshwari Vikroli Link Road
Kanjurmarg (East), Mumbai 400 042
India
Phone: +91 22 6152 9700
Fax: +91 22 6152 9777

Sandoz Private Limited, API Plant
Plot No. 1 L-1, Additional MIDC
MIDC Industrial Area
Mahad / Dist. Raigad 402 301
India
Phone: +91 2145 235000
Fax: +91 2145 251066

Novartis India Limited
MIDC, Plot No. 8-A/2, 8-B
T.T.C. Industrial Area, Kalwe Block
Village-Digha, Opp. Thane-Belapur Road
Navi Mumbai 400 078
India
Phone: +91 22 2763 9000
Fax: +91 22 2763 9064

Sandoz Private Ltd, Turbhe Production Site
Plot Nos. D-31 & D-32
MIDC TTC Industrial Area Turbhe
Turbhe, Navi Mumbai 400 705
Phone: +91 22 6793 0100
Fax: +91 22 6793 0142
India

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Bostonian_04 on April 11, 2016, 09:26:33 PM

Great to hear than Jadenu is approved in Canada. It is such a blessing to have this drug available to kids that can swallow pills.

Hoping it will be approved in India soon. The only thing I will say about Jadenu is please have it with food....then stomach issues do not arise.

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on April 11, 2016, 10:07:35 PM

Thank you Bostonian_04, that is helpful as lil A is starting Jadenu sometime over the next few weeks.

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Bostonian_04 on April 21, 2016, 04:32:57 AM

Sharni,
How is little A doing with Jadenu? Is he coming to San Diego for the Thal Conf? We are planning to take our daughter this time so that she can meet kids that are just like her. Currently she is the only one in her school and in our community. Also we go to Children's hospital's satellite center so again we don;t get to meet anyone similar to her medical condition.

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on April 21, 2016, 03:43:58 PM

Hello Bostonian,

So we have hit another hurdle, my husband's health care plan at work requires that the DIN number be added to the provincial list of covered drugs.  I was so excited to take the prescription to the drug store only to learn of this!   :banghead :banghead :banghead

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Canadian_Family on May 25, 2016, 07:25:53 PM

My insurance company ruled it to be eligible for coverage. We will be proceeding with Jadenu in couple of months (Little Miss A is enjoying vacation from exjade, her iron levels are too low to be chelated).

Sharmin,

Please check again with your insurance company, they are coming on-board.

Title: Re: Jadenu Approval in Canada Possibly February 2016
Post by: Sharmin on May 25, 2016, 10:49:36 PM

Thank you Canadian Family,

Our insurance company approved it now as well.  I'm glad little miss A will be switching too - I've heard good things from parents of young children. 

We hope to start in July.  Hopefully all goes well :)

What a difference these oral chelators have made.  Patients could not have imagined ferritins below 1000 just a decade ago. 

Thanks again,

Sharmin